What's New - July to August 2002

Inveresk Research Signs License Agreement with InnaPhase Corporation

InnaPhase Corporation, a leading provider of enterprise technology solutions for life sciences, has announced that the Inveresk Research Group, one of the largest contract research organizations in the world, has signed a license agreement to implement InnaPhase's Watson Laboratory Information Management System (LIMS). This most recent agreement provides Inveresk with Watson licenses for their European Headquarters in Tranent, Scotland and for CTBR in Montreal, Canada. The Watson LIMS system is specifically designed to support DMPK/Bioanalytical studies in drug development while ensuring regulatory compliance with the FDA's 21 CFR Part 11 guidance on electronic records and signatures. Watson has an established track record of accelerating bioanalysis, sample management and regulatory compliance in pharmaceutical drug development. For details, visit http://www.innaphase.com.

InnaPhase Signs Global Agreement with Merck KGaA for EP Series

InnaPhase Corporatio and Merck KGaA have signed a license agreement for InnaPhase's Enterprise Pharmacology (EP) Series product. This most recent agreement provides Merck KGaA with EP Series licenses in their research facilities in Germany, France and the United States, while extending the use of InnaPhase's Kinetica, a powerful PK/PK analysis tool, throughout their pre-clinical and clinical laboratories worldwide. The EP Series is a technology solution that centralizes the analysis and management of PK/PD data. This protocol-driven system provides intelligent data import and export, a flexible cross-study data-mining tool and powerful PK/PD data analysis, simulation and reporting capabilities. EP Series includes an Oracle-based PK/PD data repository, GLP and 21 CFR Part 11 compliant security and audit agents. "Using the EP Series will significantly accelerate our analysis and result interpretation turnaround," said Andreas Kovar, Ph.D., Global Head of Clinical Pharmacokinetics for Merck KGaA. "On-demand PK/PD information access combined with improved knowledge sharing on a global basis will allow us to make more informed decisions, provide seamless drug development processes and cost savings within our organization." For details, visit http://www.innaphase.com or http://www.merck.de.

Nautilus LIMS Chosen to Automate DNA Analysis and Biotechnology Processes for New Zealand Dairy Industry

Thermo LabSystems has announced that GeneMark, the largest commercial bovine DNA-analysis service in New Zealand, is to implement Thermo LabSystems' Nautilus LIMS to support its scientists in the automation of laboratory and associated activities. Based in Hamilton, New Zealand, and operated and owned by Livestock Improvement Corp Ltd, GeneMark offers a range of DNA-based testing and services to ensure New Zealand farmers benefit from advances in biotechnology. These services include single gene testing, parentage testing, DNA extraction, and DNA sample storage. Laboratory processes to be automated through the deployment of Nautilus include sample submission, laboratory processes, and results interpretation and processing. Commenting on the decision to select Nautilus, GeneMark Manager, Simon Yarrow, said: "Nautilus is a critical element in our plans to expand the services offered by GeneMark as a high-throughput commercial DNA testing facility for the New Zealand bovine industry. This investment will provide GeneMark with an integrated solution to meet our current and identified future requirements". Regarding system functionality, Yarrow added: "In particular, the plate handling and its ability to integrate with instruments is strong, the user interface is very intuitive, and the configurability of the package is a real plus." Launched in June 1999, GeneMark holds more than 50,000 animals' DNA profiled on its database, and this continues to grow daily. Several different types of sample are submitted, including blood, hair, and semen. GeneMark's laboratory processes are carried out on 96-well or 384-well plates. Nautilus will be integrated with a range of laboratory technology including PCR robotics, automated sequencers, and gene mapping software used for high-throughput automated allele calling. For details, visit http://www.thermolabsystems.com

EMBL and Thermo LabSystems Collaborate in LIMS Enhancement to Support Functional Genomics Operations

Thermo LabSystems has finalized an agreement with the European Molecular Biology Laboratory (EMBL) to collaborate in the enhancement and implementation of Thermo's Nautilus LIMS to meet EMBL's specific data-management requirements for its Genomics Core Facility (GeneCore) operations. EMBL anticipates that the project will result in improvements to its operational and quality-control efficiency through the automation of laboratory operations and enhanced data-management capabilities. The solution will be deployed at EMBL's main laboratory in Heidelberg, Germany. Dr Jürgen Zimmermann, who leads the project in the GeneCore facility, commented: "The flexibility and user-friendliness of Nautilus makes it one of the most powerful laboratory information management tools available. We are looking forward to working alongside Thermo to enhance the system to meet the challenging demands that exist in the areas of micro-array production, serial analysis of gene expression (SAGE), and DNA sequencing." The requirement to automate micro-array production is the most demanding aspect of the development project, including advanced functionality for array production for cDNA, oligonucleotides, and proteins. EMBL will integrate Nautilus with its wide range of laboratory instrumentation and data analysis software. EMBL's contribution to the project includes intellectual know-how and resources for implementation and validation. For details, visit http://www.thermolabsystems.com

Thermo LabSystems Acclaimed with Top Strategic Marketing Honors in New North American LIMS Survey

Thermo LabSystems has been presented with the Growth Strategy Marketing Engineering Award by Frost & Sullivan as a result of a survey on the U.S. LIMS Market, published July 25, 2002. In preparing the report, Frost & Sullivan surveyed more than 150 informatics vendors in the North American marketplace. Explaining the award, Frost & Sullivan cited the variety of approaches Thermo LabSystems has taken to increase sales and market share in a rapidly changing market. In addition to acknowledging the strength of the company's two main products, SampleManager and Nautilus LIMS, Frost & Sullivan recognized Thermo's initiatives in offering deployment of LIMS using the Application Service Provision (ASP) model and the launch of specific LIMS functionality in Nautilus for biotechnology applications. In October 2001, Thermo LabSystems was named among the top ten bioinformatics companies in a Frost & Sullivan's analysis report, "The U.S. Bioinformatics Market." For details, visit http://www.frost.com or http://www.thermolabsystems.com

LabVantage Solutions to Enter into Marketing Agreement with Matrix Science for Streamlined Protein Identification

LabVantage Solutions, Inc., a leading provider of Discovery Lifecycle LIMS and Enterprise LIMS solutions, and Matrix Science, a market leader in protein identification software, have announced a marketing agreement to integrate Sapphire Informatics with Mascot. Mascot Software, Matrix Science's lead product, is a software suite for protein identification that enables mass spectrometry (MS) data to be rapidly matched against protein or nucleic acid sequence databases. The search engine is ideal for high-throughput applications and closed loop automation."This relationship addresses the needs of proteomics labs that are looking for a powerful off-the-shelf solution to integrate and automate their protein identification workflow," said Director of Matrix Science John Cottrell. "I look forward to a successful relationship with LabVantage Solutions." "The strength of LabVantage Sapphire Informatics is in its ability to act as the information hub for researchers across various disciplines of discovery. This newly formed relationship will provide Sapphire customers with a means to quickly search their mass spec data with Mascot's Peptide Mass Fingerprint search, MS/MS Ions search or Sequence queries," said LabVantage's Director of Global Informatics Marketing Joe Peden. For details, visit http://www.matrixscience.com or http://www.labvantage.com.

LabVantage Solutions Signs Co-marketing Agreement with OmniViz for Improved Decision Support

LabVantage Solutions, Inc. and OmniViz, Inc., a leader in information visualization and data mining solution technologies for life and chemical sciences, have announced a marketing agreement and the successful integration of their products. This partnership is expected to help world-class research organizations in their efforts to enhance operational and research efficiencies by utilizing the OmniViz decision analytics software to access mission critical data stored in LabVantage Sapphire Informatics. Leveraging OmniViz software tools, LabVantage customers will gain one of the industry's most comprehensive and scalable solutions for rapidly accessing, analyzing and visualizing data. OmniViz's strength is in allowing the user to analyze text documents and numerical, categorical, and genomic sequence data in an integrated manner. OmniViz reveals previously unknown relationships without the need for prior knowledge. Other data mining tools simply provide a way to test previously held hypotheses. These tools often miss the truly significant discoveries embedded in large databases. "Researchers and scientists in bioinformatics and cheminformatics will now be able to quickly access the dynamic data within LabVantage Sapphire Informatics, analyze the information in OmniViz and return those results back into Sapphire," said Jeff Saffer, acting president, of OmniViz, Inc. "This will enable users to discover the unexpected and rapidly make more informed decisions about their information, which will further reduce discovery and development costs." "The strength of Sapphire is in its ability to meet the most demanding data management and analysis requirements," said Scott Deutsch, vice president global marketing, LabVantage Solutions. "LabVantage customers are always looking for better ways to gain analytical insight into their vast array of scientific data. They will be impressed with the visualization and data mining capabilities available in OmniViz." For details, visit http://www.OmniViz.com or http://www.labvantage.com.

LabVantage Solutions to Enter Into Marketing Agreement with Celadon Laboratories for Advanced Oligonucleotide Primer Design

LabVantage Solutions, Inc. and Celadon Laboratories, providers of cutting-edge software for designing and selling oligonucleotide assays for SNP and gene expression analysis, have announced their intention to integrate and co-market their products ProbeITy and LabVantage Sapphire for oligonucleotide assay design. This agreement helps streamline the resource intensive assay design process and provides an integrated Discovery Lifecycle framework for research. ProbeITy determines the optimal structure of primer and probe sets for DNA tests by batch-processing sequence data of genes and suggesting best sequences for creation of tests. For customers who seek to sell oligonucleotide assays, Celadon provides an e-commerce as well as a design function. This product can produce far superior results in a fraction of the time currently spent by researchers. Using ProbeITy, even untrained personnel can perform in minutes the work that can now take an experienced scientist hours or days to perform. For any given DNA test, there are hundreds of potential designs. However, only a tiny fraction of these produce an accurate and reliable test. To design an optimal test, every one of the hundreds of possibilities needs to be examined. Despite this, existing software acts more like a calculator, examining small portions of molecular sequences individually, and forcing scientists to evaluate each possible design one by one. "By contrast, Celadon's ProbeITy software is unique because it is the only software that can design a DNA test for any genomic method, chemistry, or instrument simply by inputting data. The software automatically evaluates hundreds of different molecular sequences simultaneously by applying sophisticated algorithms, and leading scientists through the exact sequence of steps needed to design an accurate and reliable test," said Celadon's Chief Executive Officer, Lawrence A. Kessner. "ProbeITy in combination with LabVantage Sapphire Informatics is a world-class offering that will help researchers reduce inefficiencies in their time-sensitive processes." For details, visit http://www.celadonlabs.com or http://www.labvantage.com.

ChemWare and NuGenesis Technologies Announce OEM Agreement

ChemWare Inc. and NuGenesis Technologies Corporation have announced an OEM agreement that brings to ChemWare's customers a LIMS solution that incorporates NuGenesis' Scientific Data Management System (SDMS) as a data foundation for ChemWare's HORIZON LIMS. Environmental and clinical laboratories, especially large network labs with diverse instrumentation and data systems, face major productivity hurdles in collecting, reviewing and reporting lab results. The problem is exacerbated by the fact that most instrument records are reduced to paper, making the assembly of final reports a labor-intensive, manual process. NuGenesis SDMS offers scientists, managers, and technicians browser-based access to an automatically aggregated repository that contains all instrument data generated in the enterprise. By integrating NuGenesis SDMS with HORIZON, all lab results for a given sample or sequence, including graphical output, are available to the knowledge worker for online review. In addition, the HORIZON-NuGenesis SDMS solution provides 21 CFR Part 11 compliant electronic signatures, data security, and complete audit trails for instrument reports, methods, and raw data files. For details, visit http://www.chemware.com or http://www.nugenesis.com.

NuGenesis Technologies and Spotfire Develop Integrated Data Management and Analytics Strategy for Life-Sciences

NuGenesis Technologies Corporation and Spotfire, Inc. have announced a new interoperable platform for dynamic analysis, and collaborative reporting using advanced scientific data management and analytic techniques. The integration of the NuGenesis Scientific Data Management System (SDMS) and Spotfire's DecisionSite analytic application will simplify the decision process for scientists working in information intense environments. The ability to automatically capture, process and visualize data from disparate sources using an integrated program allows scientists to maximize the value of their data quickly and easily. "This is a comprehensive solution for managing and correlating the vast amounts of high throughput data throughout the R&D process in the biopharmaceutical industry," says Dave Levy, Vice President, Product Management, NuGenesis Technologies Corporation. "Because complex scientific analysis requires a compilation of many different types of instruments and software programs, the interoperability of a relational database repository with an analytics software package is critical to determining accurate conversion of raw data to interpreted information and knowledge." Over the next decade, data repository aggregation and associated analytics will be a key 'foundation' strategy for corporate information technology planning at modern biopharmaceutical organizations. The rapidly expanding data landscape in the drug discovery process requires a comprehensive scientific data management infrastructure and analysis technology to support it. For details, visit http://www.nugenesis.com or http://www.spotfire.com.

PerkinElmer Life Sciences Introduces Gene Expression Software

PerkinElmer Life Sciences has introduced ArrayInformatics, a software solution for storing, organizing and evaluating gene expression microarray data. The ArrayInformatics database and visualization tool product set can organize, track and integrate data as a relational set of links, across every step in the gene expression workflow process. Using the software, researchers can capture and integrate microarray data flow from instruments and other software packages. Researchers using gene expression tools for drug discovery, gene expression profiling, and other genomics-related efforts can publish results quickly and compare results with colleagues in a standardized format. For details, visit http://www.perkinelmer.com/lifesciences.

PerkinElmer Launches New Gas Chromatography Line

PerkinElmer Instruments has announced the release of its new Clarus 500 Gas Chromatograph (GC) and Gas Chromatograph/Mass Spectrometer (GC/MS), offering a revolutionary approach to GC instrument control. An intuitive touch screen features real-time signal display and supports seven languages. Unique features, such as a fast rotating autosampler tower, a PreVent pressure control system, and easy serviceability, enable the Clarus systems to deliver maximum GC productivity. Available in customizable configurations ranging from dedicated analyzers for petrochemical applications to powerful mass spectrometer units for environmental and forensics applications, the sleek Clarus 500 GC is extremely flexible. For applications requiring mass spectrometer detection, the Clarus 500 GC can be coupled to the new Clarus 500 MS, the industry's fastest scanning and widest mass range quadrupole mass spectrometer, allowing users a greater scope of applications. For details, visit http://www.perkinelmer.com/instruments.

Applied Biosystems Releases New ABI Prism 3100 Data Collection Software v1.1

Applied Biosystems has released ABI Prism 3100 Data Collection Software v1.1 at no charge to customers. The upgrade includes a new module that allows ultra-rapid sequencing in just 40 minutes. It also requires only one polymer type and array length to perform multiple applications. Sequencing and genotyping samples can now be analyzed automatically, quickly, and accurately without changing either the polymer type or capillary array length. Designed for the ABI Prism 3100 Genetic Analyzer, the new 3100 Data Collection Software v1.1 provides much greater flexibility for laboratories engaged in a wide variety of applications, including SNP genotying and validation, microsatellite analysis, and sequencing. For details, visit http://www.appliedbiosystems.com.

Scientific Software Releases Version 3.0 of EZChrom Elite Chromatography Data System

Scientific Software, Inc has released version 3.0 its EZChrom Elite Chromatography Data System. This version, which was focused on the needs of pharmaceutical customers, brings greater convenience in achieving US FDA's Part 11 compliance and reduced 'time-to-validation' with electronic signature enhancements, expanded activity logs, and Citrix Metaframe XP support for thin client access. New enhancements include: A signing authority hierarchy which can work with a company's SOPs to enforce proper application of electronic signatures to data; Thin client interaction via Citrix Metaframe XP support; Expanded activity logs and audit trails; Full integration with the Varian 9000 GC and complete VICI valve control; Support for the Shimadzu LC-2010; and, Full TCP/IP support of Agilent GCs and LCs. For details, visit http://www.scisw.com.

Agilent Technologies and Scientific Software to Integrate Systems for Pharmaceutical Quality Assurance

Agilent Technologies Inc. and Scientific Software Inc. have announced they will develop and market the integration of Scientific Software's CyberLAB Knowledge Engineering System and Agilent's networked data systems (NDS), including Agilent ChemStation Plus and Agilent Cerity NDS for Pharmaceutical quality assurance/quality control (QA/QC). The alliance will benefit analytical laboratories in the life sciences field by providing fully compliant solutions for acquisition, management and long-term storage of raw and meta-data to ensure regulatory compliance and improve productivity in the drug discovery, development and manufacturing process. CyberLAB is a Web-based knowledge engineering system designed to manage all types of information across an enterprise, building an entire electronic library for informed decision making and enabling regulatory compliance with the U.S. Food and Drug Administration's ruling on electronic records and signatures (21 CFR Part 11). Agilent's NDS solutions provide modular software components for instrument control, data acquisition and data management. For details, visit http://www.agilent.com or http://www.scisw.com.

Agilent Technologies Licenses Spotfire's DecisionSite Analytics Platform for Its Life Sciences Informatics Solutions

Agilent Technologies Inc. and Spotfire Inc. have announced that Agilent has licensed Spotfire's DecisionSite analytic application platform, which will be used in Agilent's informatics solutions to assist scientists in the areas of disease and drug discovery. Spotfire's DecisionSite platform allows independent software vendors and partners to configure and add knowledge and value to Spotfire's analytic applications. DecisionSite's dynamic user environment, open architecture and application programming interfaces (APIs) make it easy for partners such as Agilent to develop and support independent analytic solutions. Spotfire DecisionSite allows product developers, scientists and researchers to test hypotheses based on millions of datapoints. More than 10,000 chemists and biologists use Spotfire DecisionSite at all major pharmaceutical and biotech companies throughout the world. For details, visit http://www.spotfire.com or http://www.agilent.com.

Rosetta Biosoftware and Agilent Technologies Introduce the Rosetta Luminator System

Rosetta Biosoftware and Agilent Technologies Inc. have announced the introduction of the Rosetta Luminator system, a client-server bioinformatics system for storing and analyzing microarray data. The Rosetta Luminator system will be distributed exclusively by Agilent, which already has an exclusive arrangement with Rosetta Biosoftware to distribute the Rosetta Resolver system targeted towards large pharmaceutical companies and major research facilities. The Rosetta Luminator system was developed to meet the needs of small- to medium-sized pharmaceutical and biotechnology corporations, as well as academic laboratories and core facilities involved in gene expression research. The system is designed to grow with the needs of the gene expression researcher, and provides a seamless upgrade path to Rosetta Biosoftware's flagship enterprise gene expression data analysis product, the Rosetta Resolver system. Version 1.0 of the Rosetta Luminator system includes a subset of the features from the Rosetta Resolver system, which is designed for use by research organizations that have the need to analyze and manage large volumes of expression data in a variety of formats. The Rosetta Luminator system leverages Rosetta Biosoftware's advanced technology-specific error models to assign P-values and error bars to every single gene expression data point. This facilitates the identification of genes with significant present/absent calls or up/down regulation at a desired confidence level. The quality statistics calculated by these error models automatically take advantage of experimental replicates, and are used by every analysis feature of the system to produce optimal results. Like the Rosetta Resolver system, the Rosetta Luminator system has the integrated capability of analyzing ratio and intensity data in one system, negating the need for separate modules or products to analyze various data formats. The system also provides a centralized Oracle database to locally warehouse all microarray data and relevant experiment annotations. The Rosetta Luminator system's annotative LIMS capabilities enable customers to import and store information related to their gene expression experiments. For details, visit http://www.rosettabio.com/products/luminator or http://www.agilent.com.

Agilent Technologies and Accelrys Announce Software Licensing Agreement and Technology Alliance

Agilent Technologies Inc. and Accelrys Inc., a wholly owned subsidiary of Pharmacopeia Inc., have announced a software licensing agreement and technology alliance expected to result in software to assist pharmaceutical and biotech professionals in the development of more effective drugs. Under the terms of the agreement, Agilent will license the use of Accelrys' Viewer ActiveX Control for 3D visualization of molecular structures. The Viewer ActiveX Control will be integrated into the recently released Agilent Synapsia Informatics Workbench, and will enable scientists and technicians in the pharmaceutical and biotech industry to visualize and share molecular information in a clear and consistent manner across the pharmaceutical value chain. It is expected to further enhance the collaborative knowledge synthesizing capability of Agilent's Informatics software, and therefore help accelerate decision-making in the development of more effective drugs. For details, visit http://www.accelrys.com or http://www.agilent.com.

Agilent Technologies and IBM Announce Agreement to Help Accelerate Drug Discovery and Development

Agilent Technologies Inc. and IBM have announced an agreement to bring together complementary technologies to create an informatics system designed to help accelerate drug discovery and development. Through the agreement, the companies will collaborate to make IBM's DiscoveryLink data integration technology compatible with the new Agilent Synapsia Informatics Workbench family of software products. Synapsia is designed to help researchers synthesize and share research knowledge. The combined Agilent and IBM technologies will enable researchers to access and perform queries against a broad range of biological and chemical data from diverse sources and in different types of files and formats, including text, images, numeric files, and relational databases. Using DiscoveryLink, researchers can search diverse data sources, such as relational databases -- Oracle and Sybase systems, for example -- and public bioinformatics and genomics databases. Through its federated approach to data management, DiscoveryLink can perform complex searches quickly and efficiently, and deliver results in a consolidated, consistent format, while leaving the original data and its underlying structure intact. For details, visit http://www.ibm.com/solutions/lifesciences or http://www.agilent.com.

Zymark Introduces New Systems Integration Software

Zymark Corporation has announced the release of CLARA 2.2, the third iteration of the CLARA software suite. A drug discovery automation solution, CLARA incorporates plug-and-play resource adapters to provide simplified environmental setup. Any instrument in the automated system is instantly identified by CLARA and ready for drag and drop assay creation. CLARA has more than 100 adapters for third party instruments. In addition CLARA's optimization tools have been enhanced to further improve assay automation and throughput. The application scheduler has also been updated, increasing computational speed. A new real-time Gantt Chart displays run-time progress and completion of instructions. For details, visit http://www.zymark.com.

GMP Revisions to Reduce Drug Plant Inspections

As part of the FDA's new initiative to revise the good manufacturing practice (GMP) program, the agency has announced that it will conduct fewer on-site inspections of drug manufacturing facilities by limiting examinations to facilities that have been designated "high-risk." The revamping of the GMP program follows several high-profile cases of violations at drug manufacturing facilities. However, the FDA denied the initiative resulted from the recent violations. "Twenty-five years have passed since the last major revision of the program, and advances in drug making technologies require its re-evaluation," said Janet Woodcock, the director of the FDA's Drug Center, during an August 21 teleconference announcing the agency's blueprint for action. For details, visit http://www.fda.gov.

New Zealand to Begin Regulating Devices

New Zealand likely will copy some pending Australian device rules - which mirror the European system and are set to take effect October 5, 2002 - as it develops a plan for regulating devices. Currently, New Zealand has neither premarket approval requirements nor any kind of manufacturer or product registration. However, the country has legislation allowing authorities to remove unsafe products from the market. New Zealand does not plan to introduce a full premarket approval system, said Peter Pratt, team leader for compliance at the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE). "For a small market, the cost of having our own complex evaluation system would be too much for industry," he said. "We want to put in a system that reflects current business practice and is globally acceptable and doesn't place too heavy an entry burden on industry." Pratt said that a voluntary product and manufacturer registration program is likely, and could be up and running by mid-2003. For details, visit http://www.fda.gov.

Australia and New Zealand May Set Up Joint Agency

Australia and New Zealand may pool their resources and set up a one-stop approvals shop for devices and pharmaceuticals seeking to enter both markets. The two countries are likely to model the joint agency on the European Medicines Evaluation Agency, which has been operational since January 1, 1995. An Australian official said the new agency may be established in 2004. However, there are still some sticking points to address. Because New Zealand officials are struggling to develop a regulatory framework for devices, that country probably would adopt some or all of the existing Australian regulations. But in the drug field, New Zealand already has its own regulations, so the two nations need to negotiate a hybrid system. For details, visit http://www.fda.gov.

PDUFA III Could Save Drug Makers Money

Drug industry representatives are applauding the new fee schedule released last week by the FDA under the Prescription Drug User Fee Act III (PDUFA) despite a dramatic increase in rates. While sponsors will have to pay $533,400 for an application requiring clinical data to receive expedited review - almost double the previous fee - expedited reviews can shave millions of dollars from development costs. The fee schedule is the result of eight months of negotiation between federal regulators and industry. Both sides agreed that the user-fee program needs to generate about $1.2 billion over the next five years. The money will allow the FDA to add 450 full-time employees - most of whom will serve as additional drug reviewers - and to spend about $70 million to assist post-market surveillance. It will be the first time drug companies have agreed to help pay for their own post-market surveillance. The $1.2 billion represents a 6 percentage point increase - from 51 percent to 57 percent - in the portion of the drug approval process that is paid for by sponsors, said Pharmaceutical Research and Manufacturers of America spokesman Jeff Trewhitt. "That is a necessary development at a time when Congress has appropriated only stagnant funding to an agency with growing responsibilities," he added. For details, visit http://www.fda.gov.

Drug Makers May Face New Clinical Trial Rules

The National Human Research Protection Advisory Committee (NHRPAC) is considering new rules that would tighten up consent requirements meant to reduce risks of clinical drug trials involving children, the mentally ill or other vulnerable populations. The NHRPAC's working group on decisional incapacity recommended that study sponsors be required to get permission from a legally authorized representative before enrolling mentally impaired persons in clinical trials, even during minimal-risk procedures. For trials involving greater risk, research should be conducted or funded only if the drug being tested would provide adequate benefit to the research subject, the group advised. For details, visit http://www.fda.gov.

E.U. Won't Require Reformatting Into CTD

Drug makers will not be required to reformat files of already approved products into the common technical document (CTD) layout next year, according to a European Commission question-and-answer paper on the new standard international application format. The CTD, which was developed under the International Conference on Harmonization (ICH) process, will be mandatory for all new drug applications filed in the E.U. starting July 1, 2003. Drug makers can opt to use the CTD for existing drugs, but the Q&A paper said it is "not recommended" for nonclinical and clinical parts of the documentation. For sections pertaining to quality, the companies are "encouraged" to use the CTD. To see the Q&A paper, go to http://pharmacos.eudra.org/F2/eudralex/vol-2/B/CTD-QA.pdf.

Senate Passes Patent Reform Bill

A bill designed to accelerate the introduction of generic drugs by making it more difficult for brand-name drug makers to extend their patents passed the Senate in a 78-21 vote. The bill now goes to the House, which will return from its summer recess September 3, 2002. The patent-reform provisions in S. 812, sponsored by Sens. John McCain (R-Ariz.) and Charles Schumer (D-N.Y.), would restrict brand-name companies to one 30-month stay on generic approvals, which occurs when a generic firm challenges a brand drug's patent and the brand maker files an infringement lawsuit. The stay would be restricted to a brand maker's original patents. Some brand-name companies have filed "spurious" patents to win continuous delays, generic companies have complained. The provisions are supported by the Generic Pharmaceutical Association but strongly opposed by Pharmaceutical Research and Manufacturers of America, which represents brand makers. The Senate also defeated a Medicare prescription drug plan that would provide a government-funded 5 percent discount on all Medicare beneficiaries' prescription drug costs. The plan, offered July 30 by Sens. Bob Graham (D-Fla.) and Gordon Smith (R-Ore.), was offered as an amendment to S. 812. It would have cost $390 billion over 10 years and been administered by pharmacy benefit managers. It also would have provided catastrophic coverage for beneficiaries whose drug purchases exceeded $3,300 in annual out-of-pocket spending, as well as co-insurance for Rxs purchased by beneficiaries whose incomes were less than 200 percent of the federal poverty level. The Graham-Smith plan was defeated in a 50-49 vote, falling 11 votes short of the 60 votes needed to pass under the Senate's budget rules. The Senate also recently defeated three other Medicare Rx bills that were offered as amendments to S. 812. In June, the House passed H.R. 4954, which would create incentives for private insurance companies to provide Medicare Rx coverage. For details, visit http://www.fda.gov.

Bar Code Task Force Urged by Drug Groups

Two drug industry associations urged the FDA to form a task force to map out what would have to be in place within the healthcare industry before a rule is issued requiring the use of bar codes on drugs. In addition, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Generic Pharmaceutical Association (GPhA) said they support creating the task force to study what should be included in automatic identification code regulations. PhRMA and GPhA made the recommendation to an FDA panel, which convened at the National Institutes of Health to hear comments from stakeholders that the agency could use when drafting a bar code regulation. The FDA said a proposed rule could be ready by November 2002. For details, visit http://www.fda.gov.

New Report on Canadian Biotech Industry Available

D&MD has released a new Executive Briefings report entitled Canadian Biotech: Where the Opportunities Are. The report highlights the growth in Canadian biotech, which has export revenue projected at $1.7 billion by year end 2002. The report is comprised of 250+ pages, 90+ exhibits, 3 case studies, and 24 company profiles. For details, visit http://www.drugandmarket.com/9063.

Laboratory Informatics 2003 Call for Papers

The LIMS Institute has announced that it has undertaken a partnership with the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy to present Laboratory Informatics 2003 as a conference-within-a-conference at PITTCON 2003, March 9-14, 2003 in Orlando, Florida. Laboratory informatics can be broadly defined as the specialized application of information technology and automation to optimize and extend laboratory operations. It encompasses all aspects of laboratory data flow, from instrument data acquisition, to laboratory information processing, to enterprise knowledge management. It deals with fundamental issues common to all laboratories, including hardware connectivity, systems integration, validation and compliance, application selection and implementation, and automation of operations. It also focuses on specific solutions to the specialized needs of laboratories in different industries. This conference will be the first of its kind devoted exclusively to this emerging field. There will be four symposia presented exclusively by invited speakers, a special exhibit area, and contributed paper sessions. This is a call for papers for the Laboratory Informatics Contributed Paper Sessions. These sessions will provide a forum for professionals from different laboratory environments: academic, commercial, and municipal; analytical, clinical, environmental, and forensic; production and research; small companies, major corporations, hospitals, and universities. Abstracts should be submitted via the PITTCON Web site (www.pittcon.org). Click on Call For Papers under CONFERENCE on the left hand side of the screen, then click on Electronic Abstract Submission Form and then on New Laboratory Informatics Abstract. The deadline for abstract submission is August 2, 2002. For more details, visit www.limsconference.org or contact program@limsconference.org or call 724-495-3308.

Pittcon 2003 Call for Papers

The Pittsburgh Conference has issued a call for papers for Pittcon 2003 to be held March 9-14 in Orlando, FL. Pittcon is the largest analytical chemistry show in North America and brings together some 1200 companies from all over the world to listen to peresentations and visit some 3000 exhibits. Symposium topics range from applied spectroscopy and bioanalytical to environmental, nanotechnology and separations. Abstracts must be submitted by August 2. For details, visit http://www.pittcon.org.

StarLIMS to Manage the Laboratory Data of The Hong Kong Productivity Council's Environmental Management Division

L.I.M.S. USA has announced the purchase of their StarLIMS solution by the Hong Kong Productivity Council (HKPC). HKPC's Environmental Management Division (EMD) was set up in 1980 to assist business, industry and commerce sectors in devising and implementing pollution prevention and environmental management. EMD has been certified to ISO 9001 in the provision of technical consultancy services and has a HOKLAS accredited laboratory for environmental testing. EMD also provides environmental engineering services in the design and supply of pollution control systems. At present, EMD has about 90 highly trained, skilled consultants and staff to provide consultancy services. StarLIMS will provide functionality to manage all of HKPC's environmental lab's data requirements. For details, visit http://www.starlims.com/HKPC.htm.

L.I.M.S. USA Announces a National LIMS for the Environment Agency of England and Wales

L.I.M.S. USA has announced the purchase of their StarLIMS solution by the Environment Agency of England and Wales. The Environment Agency is the leading public environmental organisation within England and Wales. The Agency is responsible for protecting and improving water quality, waste management, air quality, flood defence and all aspects of fish and land conservation. The National Laboratory Service (NLS) is an integral part of the Environment Agency, providing chemical and microbiological analyses crucial to the operation of the organisation. The NLS comprises 5 laboratories (4 in England and 1 in Wales) employing over 350 dedicated members of staff. 5 million analytical tests are performed each year, in addition to the 1.5 million field measurements taken by the Agency's sampling team. StarLIMS flexibility is expected to bring harmony to this diverse organisation by handling the diverse working practices within the different laboratories. For details, visit http://www.starlims.com/nls.htm.

Thermo LabSystems to Present Latest Versions of Informatics Solutions at Drug Discovery Technology 2002

Thermo LabSystems will be presenting the latest versions of its Nautilus LIMS and eRecordManager at Drug Discovery Technology (DDT) 2002 being held in Boston, 4-9 August 2001. Thermo LabSystems will be exhibiting on Booth #1510 as part of Thermo's Life and Laboratory Science sector exhibit. In addition to supporting compliance with 21 CFR Part 11, Thermo LabSystems' solutions equip researchers and bioinformaticians with the knowledge to generate leads, terminate flawed projects early, and make more-informed decisions. New functionality for microtiter-plate processing is among the highlights of the 2002 version of Nautilus LIMS being demonstrated at DDT, including the ability to move existing aliquots to new plates, with aliquot identifiers updated automatically along with those of all related plates as they are moved between plates. The most significant advance with eRecordManager 2002 Release 1 being presented at DDT is a new Web-based client interface. eRecordManager is Thermo's solution for long-term analytical data archival and knowledge management. Booth demonstrations will show how users can now search, view, and download archived spectral and chromatographic data via a browser, without the requirement to install eRecordManager at their workstation. eRecordManager was officially launched at Pittcon 2002 in New Orleans from March 17-22, where it won the Pittcon Editors' Gold Award for best new product. For details, visit http://www.thermolabsystems.com

Thermo LabSystems Announces Program for User Conference

Thermo LabSystems has announced the program for this year's North American conference on laboratory informatics and automation. Thermo LabSystems World 2002 will be held from Monday 28th - Thursday 31st October in San Antonio, Texas. The venue will be The Westin Riverwalk Hotel San Antonio. The conference provides the opportunity for senior laboratory and IS managers from all industries to meet and discuss issues regarding laboratory informatics solutions, evolving technologies and changing market requirements. The four-day program, including technical seminars, product sessions and user presentations, has been prepared to suit both experienced users and those interested in learning more about issues concerning LIMS, chromatography solutions, electronic record management, Internet technology, regulatory compliance and instrument integration in the laboratory. Thermo LabSystems welcomes attendance by prospective customers, who can learn from experiences and knowledge of existing customers and experts. To date, confirmed industry presenters include representatives from some of the world's leading organizations including GlaxoSmithKline Genetics Division, DuPont Agricultural Products, Eastman Chemicals, AstraZeneca, IBM Life Sciences and Infinity Pharmaceuticals. Existing and prospective customers will be able to register for the event online from August 1st. Full information on the conference including a provisional agenda and venue information is available at http://www.thermolabsystems.com/events/world/northamerica/

CequeLogic Releases New Electronic Data Deliverables for Element DataSystems LIMS

In support of their current installed base, CequeLogic has released a number of new Electronic Data Deliverables [EDDs] formats for use with Element DataSystem LIMS in environmental, water and wastewater, and physical test laboratories. The new EDD formats include:
- IRPIMS (Air Force's Installation Restoration Program Information Management System)
- EDF/COELT (State of California Water Resource Control Board Electronic Reporting Format)
- EQUIS (EarthSoft's Environmental Quality Information System)
- CALTRANS (CA Department of Transportation)
- WRITE-ON (CA Drinking Water format)
- GIS/Key (GIS\Solutions' software for analysis, visualization and compliance reporting)
- As well as many other industry standard formats including XML.
The EDDs are available from the CequeLogic web site at no cost to current users. For details, and a complete list of EDDs, visit http://www.elementdatasystem.com/corporate/news/pressreleases.htm.

CREON·LAB·CONTROL and S.T. Japan Form Joint Venture

CREON·LAB·CONTROL AG and ST Japan Inc. have announced a joint venture to serve customers exclusively in the Asian region. The new company will initially establish a sales office to serve the pharmaceutical, chemical and biotechnology industries as well as the OEM business in these countries. This new venture, CREON·LAB·CONTROL Japan Inc., marks the next stage in the ST Japan's strategy to penetrate the market with state-of-the-art software technologies for the analytical laboratory. At the same time, CREON·LAB·CONTROL will gain access to customer groups from the life science sector for the increasingly specialized software business. For details, visit http://www.creonlabcontrol.com or http://www.iijnet.or.jp/STJapan/

PerkinElmer Moves LABWORKS LIMS Operations to Shelton Headquarters

Since PerkinElmer Instruments acquired LABWORKS LIMS as part of their Informatics business unit, the LABWORKS product development team has worked hard to leverage the wealth of technology resources available within PerkinElmer, including the worldwide launch of the LABWORKS product line. For example, PerkinElmer is currently developing more intelligent communications with instruments and other enterprise systems and adapting LABWORKS to address the foreign language and IT environments used in every corner of the globe. As part of this integration, the core LABWORKSdevelopment and operation team has been moved intoPerkinElmer's Shelton, CT headquarters., and the Baton Rouge, LA operations will be closed. A new number for support, sales, training and services has been activated in support of the move. The number is 800-762-4060. For details, visit http://www.labworks.com.

Accelerated Technology Laboratories, Inc.'s West Coast Office Relocates

Accelerated Technology Laboratories, Inc. (ATL) has announced that its West Coast office has expanded into a larger facility. Previously located in Reno, Nevada, the current offices are now located in Sparks, Nevada. ATL's LIMS products and data management solutions are utilized by many Fortune 500 firms to help them improve analytical data quality, reduce costs and decrease reporting time. For details, visit http://www.atlab.com.

Accelerated Technology Laboratories Inc. Provides LIMS for the Provincial Laboratory

Accelerated Technology Laboratories, Inc. (ATL) has announced it will be working with the Provincial Laboratory in Saskatchewan, Canada. ATL has implemented Sample Master Pro LIMS at the Provincial Laboratory to streamline the laboratory's data management activities, including instrument integration. The Provincial Laboratory, located in Regina, Saskatchewan, Canada, provides services that include Environmental Services, Microbiology, Chemistry and Support Services to physicians, clinics, health centers, hospitals and the general public. Provincial Laboratory receives approximately 42,000 environmental samples (drinking water, wastewater, surface water) and generates 113,000 results annually. Provincial Laboratory will utilize Sample Master Pro LIMS to analyze samples for various tests including total coliform bacteria and nitrates, automatic email notification of positive results, and produce custom reports for their customers. For details, visit http://www.atlab.com.

Accelerated Technology Laboratories, Inc. Partners with ICN Diagnostics

Accelerated Technology Laboratories has announced a new partnership with ICN Diagnostics of Costa Mesa, CA to distribute NeoMate LIMS together with their premier line of Neonatal Screening products, reagents and modular instrumentation. This partnership will provide their worldwide customer base with the total newborn screening solution. ICN is a leader in newborn screening with over three decades of expertise in providing reputable newborn screening kits, analysis systems and support at competitive prices. ATL provides LIMS and laboratory automation solutions. The partnership will allow both firms to offer their clients a complete integrated solution for their newborn screening needs from demographic entry, to result entry (both manual and via electronic data transfer) to final reporting. ATL also offers an integrated scanning package to store an image of each demographic card received by the laboratory that is linked to the patient file for future reference, a Voice Result Retrieval system, by which registered users have the ability to access the results and a web interface for remote entry of patient demographic data. For details, visit http://www.atlab.com.

Applied Biosystems and Spotfire Collaborate to Enhance Protein Expression Data Analysis

Applied Biosystems Group has announced the signing of a collaborative agreement with Spotfire, Inc, a provider of analytic software and services. The goal of the collaboration is to integrate Applied Biosystems/MDS Sciex Pro ICAT software with Spotfire's DecisionSite for Functional Genomics software. Developed through the Applied Biosystems/MDS Sciex joint venture, the integrated product is expected to represent a uniquely configured analytic application, designed to analyse protein expression data from ICAT reagent-based experiments. For details, visit http://www.appliedbiosystems.com.

Applied Biosystems and Sun Microsystems Join Forces to Produce an Informatics Solution for Glaucus Proteomics

Glaucus Proteomics has chosen Applied Biosystems and Sun Microsystems to create an efficient bioinformatics system for its R&D and production activities at its headquarters near Utrecht, Netherlands. Glaucus is a biotechnology company that develops antibody and protein arrays for the identification and characterisation of disease specific proteins to accelerate and optimise drug development and disease management. In addition, Glaucus is transforming the generation of antibodies into a fast and cost-effective process. Biocomputing represents a core element of Glaucus's activities, as do efficient solutions for management, interrogation and visualisation of complex data sets. "The critical need for LIMS implementation and an effective computing platform cannot be overestimated for the growth and development of Glaucus. The combined solution offered by Applied Biosystems and Sun Microsystems successfully met our needs for quality assurance of production, process management, and computation for complexity analysis and data storage," states professor Ian Humphrey Smith, chief scientific officer at Glaucus. "The systems put in place are built upon the knowledge-base that Applied Biosystems has gained in the cDNA biochip arena, while a multi-tier server structure, inherent reliability and redundancy, availability of dynamic partitioning and unequalled internal throughput made Sun Microsystems a logical choice." For details, visit http://www.appliedbiosystems.com.

AIS Releases AIS LIMS Version 7

Analytical Information Systems has released Version 7 of their AIS LIMS. An integrated analytical quality control (AQC) module is at the heart of this latest release. With its active AQC module, AIS LIMS Version 7 saves both time and money by instantly advising users when standards are required and warning them if target values are not being met. Another enhancement is the integrated graphical wizard that carrys out graphical analyses. Version 7 also supports integrated third-party functionality and generates output compatible with Microsoft Office documents. AIS LIMS 7 is available as 32-bit Windows software supporting industry standard database platforms such as Microsoft SQL Server 7 and Oracle. For details, visit http://www.ais-lims.com.

QSI Releases WinLIMS 5

Quality Systems International (QSI) has released Version 5 of their WinLIMS solution. This latest release incorporates a new calculation engine to provide enhanced flexibility and functionality. Virtually all mathematical functions are supported, including Boolean algebra: functions such as [IF], [THEN] etc., which are especially useful when working in the GLP or GMP environments. The software allows calculation routines that can use numeric values from anywhere within the WinLims tables, enabling techniques such as 'cross sample' calculation; i.e., the ability to incorporate results from one sample in the calculation of results for another. The product is also compatible with web technology. For details, visit http://www.qsius.com.

SYNoX Pharma Chooses NuGenesis Technologies for Scientific Data Management and Enterprise Solutions

SYNoX Pharma, Inc., a fully integrated proteomics research and development company, has chosen the NuGenesis Scientific Data Management System (SDMS) to capture and securely archive all laboratory data on an enterprise-wide basis. NuGenesis SDMS facilitates the seamless integration of information across functional groups, and provides the Clinical and Regulatory Departments at SYNoX Pharma with easy access to data and documentation to facilitate the creation of consistent and comprehensive regulatory submissions. Allison Manners, VP Regulatory Affairs at SYNoX Pharma, says, "More importantly, it improves our turn around time from clinical sample acquisition to discovery and validation of biomarkers by the ease of data sharing across different platforms." SYNoX Pharma plans to leverage the NuGenesis SDMS platform to significantly shorten the drug discovery and testing process so that products are brought to market faster. For details, visit http://www.nugenesis.com or http://www.synxpharma.com.

Scientific Software Announces Release of Version 2.1 of CyberLAB Knowledge Engineering System

Scientific Software, Inc. has announced the release of version 2.1 of its web-based CyberLAB Knowledge Engineering System(tm). This new revision provides a scalable architecture to allow CyberLAB users to globally deploy the system across their enterprise. CyberLAB KES manages any and all electronic records for an enterprise. CyberLAB enhances organizations compliance with US FDA Part 11 requirements for electronic records and electronic signature. Revision 2.1 offers many new features, including: New "n-tier" architecture allowing for a scalable solution for any number of users or instruments; A new integrated search engine that enables sophisticated queries and data mining; and, Support for Kanji characters. For details, visit http://www.scisw.com.

Agilent Technologies to Supply Incyte Genomics with Microarray Gene Expression Products

Agilent Technologies Inc. has announced that it will supply microarray gene expression products to Incyte Genomics Inc., a leading genomic information company. The supply and services agreement allows Agilent to supply Incyte with catalog and custom microarrays, microarray readers, Rosetta Resolver® bioinformatics software, and Agilent 1100 liquid chromatographs/mass spectrometry systems. "We are aggressively building our internal drug discovery research capabilities, and microarrays are a key component of today's research tool set," said Brian W. Metcalf, Ph.D., executive vice president and chief drug discovery scientist for Incyte Genomics. "This agreement with Agilent for scientific instrumentation will further our research into gene expression studies for disease and drug discovery." For details, visit http://www.incyte.com or http://www.agilent.com.

Agilent Technologies and Paradigm Genetics Announce New Microarray Kit to Accelerate Plant Genome Research

Agilent Technologies Inc. and Paradigm Genetics, Inc. have announced the commercial availability of an Arabidopsis microarray kit featuring more than 14,800 plant gene sequences derived from public domain databases. The specific gene sequences contained on one industry-standard glass slide will enable scientists to conduct high-content, genome-wide screening of Arabidopsis thaliana, a model organism used in the research and development of new plants and foods. The Agilent Arabidopsis microarray kit becomes Agilent's fifth catalog microarray kit and offers the most comprehensive coverage to date in a 60-mer commercial format. The kit resulted from combining Paradigm's extensive plant genome experience with Agilent's custom microarray Technology Access Program. In this collaboration, Paradigm Genetics used its plant genome expertise to specify, evaluate and confirm biologically relevant probes. Agilent designed the microarray using Paradigm data and used its SurePrint technology to produce the highly sensitive Arabidopsis microarray in a 60-mer oligonucleotide format. For details, visit http://www.paradigmgenetics.com or http://www.agilent.com.

Agilent Technologies to Supply Orion Genomics with Gene Expression Analysis Technology for Food Crop and Renewable Energy Research

Agilent Technologies, Inc. has announced that it will supply Orion Genomics LLC with Agilent gene expression analysis technology to accelerate Orion's enhancement of plants important in human and animal health, food production, renewable energy and other commercial applications. The technology includes a full suite of Agilent gene expression technologies, including recently released catalog Arabidopsis microarrays, automated microarray scanner and a microfluidic-based bioanalyzer. "The addition of Agilent gene expression technologies to Orion Genomics' research capabilities enables us to mine our proprietary, comprehensive gene sets to pinpoint genes responsible for specific traits of commercial interest. We evaluated alternative gene expression technologies and found Agilent's quality unparalleled," said Nathan Lakey, president and CEO, Orion Genomics, LLC. For details, visit http://www.oriongenomics.com or http://www.agilent.com.

Agilent Technologies Announces Free Chemical Analysis E-Seminars

Agilent Technologies Inc. (NYSE: A) has announced a further series of free, innovative e-seminars designed to help scientists and lab technicians advance their laboratory knowledge and skills. The latest 60-minute online seminars cover a variety of subjects such as "Analysis of Refinery and Petrochemical Products by Capillary GC," "HPLC Method Development by the Numbers," and "Secrets of Good Peak Shape for HPLC." A user-friendly Internet conferencing system allows chemists to take part in real-time, interactive courses with subjects that are highly pertinent to their work. The seminars are designed to be freely accessed anywhere; all that's required is a telephone, Internet access and an Internet browser. With content developed and conducted by industry leaders, the seminars allow online questions during live Q&A sessions by using a pop-up chat window on a PC monitor or by asking the presenter directly over the telephone. Access to the seminars is available at www.chem.agilent.com/cag/cabu/e-seminar.htm by clicking the "Events" link in the left navigation bar and then clicking on the "e-Seminars" icon. The e-seminar schedule can be viewed along with registration instructions.

New Market Analysis Report on High Throughput Screening

A new Market Analysis Report has been released by D&MD Reports entitled "High Throughput Screening, Redefining the Mission, 2nd Edition". The report is written by Ken Rubenstein and Cynthia Cody, and is available in CD-ROM and print versions. The report addresses the elements of HTS technology, market factors, current approaches, basic and applied research activities, products and applications, and company profiles. The cost is $4950. For details, visit http://www.drugandmarket.com.

ChemSW CD-ROM Demonstrates over 30 Mass Spec and Chromatography Software Programs

ChemSW, Inc. has announced the publication of a new CD-ROM collection of reference tools for mass spectrometry and chromatography. The CD presents demonstrations of more than 30 ChemSW software programs for the chemistry lab and features a complete list of over 40 books from Global View on mass spec and gas chromatography topics. Among the software demonstrations are Mass Spec Calculator Pro, NIST/EPA/NIH Mass Spectral Search Library, Mass Spec Tools, Interactive Training Modules, GC and MS graph editing and protein chemistry tools. The Mass Spectrometry and Chromatography Demonstration Collection from ChemSW is available free of charge and may be ordered via e-mail at info@chemsw.com, or by calling (707) 864-0845. For details, visit http://www.chemsw.com

House Panel Approves FDA Budget

The House Appropriations Committee has approved a bill that would appropriate $1.39 billion to the FDA in fiscal year 2003. The committee's budget is $7 million more than the president requested and $16 million more than the agency's fiscal year 2002 budget, according to a committee press release. The bill was adopted on a voice vote with no dissents. The committee's appropriation includes a $4.6 million increase for the generic drug program, which will enable the FDA to review 75 percent of abbreviated new drug applications (ANDAs) within six months after they're filed, the committee report said. The bill, which hasn't been assigned a number yet, now goes to the House Rules Committee. For details, visit http://www.fda.gov