LIMSource News: What's New in March 2010

• Thermo Fisher Scientific Launches First On-Demand LIMS at Pittcon 2010

• Promium Releases Online Subscription Version of Element LIMS

• LabVantage Unveils SAPPHIRE R5.1 Laboratory Information Management Suite

• Quality Systems International Introduces VersaLIMS

• New Agilent Lab Software Suite Unifies Instrument Data Systems, Electronic Lab Notebook and Data Archival

• LabWare Releases LabWare ELN

• Waters Announces SDMS Vision Publisher

• Cerno Bioscience Announces MassWorks MS Software Support to Shimadzu LC/MS System

• Abbott Completes Acquisition of STARLIMS Technologies

• Thermo Fisher Scientific Adds The Winvale Group to Global Partner Alliance to Provide Informatics Solutions under GSA Schedule 70 Contract Procurement Process

• Thermo Fisher Scientific Equips the Scottish Metabolomics Facility with Cutting-Edge Technology to Advance the Field of Metabolomics

• Agilent Makes Fish DNA ID Fast, Simple, Accurate for Routine Testing of Seafood to Verify Species and Labeling

• Optibrium Showcases StarVue at ACS Spring 2010

• APP Pharmaceuticals Goes Live with Novatek's Environmental Monitoring LIMS

• Symbion Systems Announces Integration of its Process Analytical Technology Software with Infometrix’ Chemometrics Technology

• Agilent Technologies Facilitates Third-Party Software Control for Agilent LC Systems

• Alpha MOS Releases AroChemBase Chemical & Sensory Database

• Autoscribe Releases New LIMS Newsletter

• Symbion Systems Releases Technical Note Describing a Software Approach to Accelerating Process Analyzer Deployment

• FDA Realigns New Drug Office to Improve Review Process

• Congress May Consider Fees for Reinspections by FDA

• FDA Final Guidance Outlines Procedures for Viral Vaccine Makers

• FDA Outlines Process to Demonstrate Product Sterilization Control

• Drugmakers Ask FDA to Reconsider Social Media Policy for Drug Risks

• FDA Issues First Draft Guidance on Noninferiority Trials

• Final REMS Guidance May Be Delayed Due to Staffing Issues

Thermo Fisher Scientific Launches First On-Demand LIMS at Pittcon 2010

Thermo Fisher Scientific Inc. has announced the launch of its software-as-a-service (SaaS), enterprise-class laboratory information management system. LIMS-on-Demand allows organizations of varying types and sizes to leverage all the benefits of an industry-leading LIMS solution without the time and cost typically associated with on-premise software installation. LIMS-on-Demand can significantly reduce the capital investment associated with traditional LIMS implementation and validation by eliminating the need for extensive software testing and installation. On-demand access provides a more flexible alternative to conventional LIMS so organizations can more easily and cost-effectively adapt technology as needs change. For the cost of a monthly subscription fee, a laboratory can easily, affordably and securely access a fully-functional, validated solution through a standard Web browser. The intuitive Web interface enables connectivity with a variety of internal instruments and systems as well as external facilities, partners and regulatory agencies. LIMS-on-Demand offers flexibility and ease-of-use, helping organizations replace inefficient, error-prone manual processes with an automated data management solution. Customers can create workflows, map sample lifecycles and generate automatic updates while providing users with rapid access to up-to-the-minute data and information that impacts every phase of laboratory processes. "LIMS-on-Demand delivers the benefits of an on-premise LIMS at a lower cost and with very little implementation time," said Dave Champagne, vice president and general manager of Thermo Fisher Scientific's Informatics business. "With built-in workflows, the ability to capture, store and analyze lab data, monitor resources and integrate with instrumentation, we are enabling more laboratories around the world to experience the competitive advantages of LIMS." For details, visit http://www.limsondemand.com.

Promium Releases Online Subscription Version of Element LIMS

Promium, LLC has announced the availability of a subscription service offering for their Element DataSystem LIMS . Element had previously been available primarily as a licensed desktop software application. The subscription version of Element from Promium, provided through a SaaS (software as a service) implementation, offers all the same functionality and configurability of the desktop software. While the company still sees a strong preference for desktop software, more and more laboratories are seeking an option with a lower capital outlay and lower operating cost. Using the Internet and incorporating Microsoft remote access technology, Promium gives lab operators and IT administrators a new alternative for deploying LIMS functionality throughout the lab that has a zero IT footprint. "A subscription option for Element gives our customers one more choice with regard to how they build out their information infrastructure," said Scot Cocanour, Promium CEO. "They get the same LIMS functionality and the same support but without having to buy additional computer servers or add IT overhead to manage that infrastructure." In addition to reducing capital outlay and IT operating expenses, the subscription service can also lower business risks. Element is hosted in a secure and redundant data center facility with protocols in place to protect against and mitigate hardware, software, infrastructure and communications failures and interruptions. Using technologies that many labs simply can’t afford, the data center has fully redundant hardware and software platforms and includes the capability for back-up at a second location. Promium launched the subscription service in order to address a growing desire of labs to reallocate their resources in order to increase efficiency. "The key to improving productivity is ultimately implementing a great LIMS," said Cocanour. "Whether you buy, lease or subscribe the most important thing is to get that LIMS in place. The increased productivity, improvements in quality control and superior access to data will differentiate the lab in the marketplace and deliver bottom line results." Subscriptions are available in monthly or annual contracts. For details, visit http://www.promium.com.

Labvantage Unveils SAPPHIRE R5.1 Laboratory Information Management Suite

LabVantage has announced the availability of its SAPPHIRE Release 5.1 Laboratory Information Management Suite (LIMS). SAPPHIRE is an industry-leading zero footprint and configurable off-the-shelf (COTS) LIMS that consolidates functionality typically found in multiple laboratory systems. SAPPHIRE is readily tailored to manage an organization's laboratory information across its worldwide R&D pipeline and manufacturing supply chain. “The R 5.1 release represents another critical milestone in product innovation for enterprise laboratory informatics, further extending SAPPHIRE’s functionality to support operations in the clinical space,” states David Ciabattoni, Senior Director, Software Development of LabVantage. This is also aligned with LabVantage’s development philosophy to continuously broaden the spectrum of SAPPHIRE’s functional features on a powerful, pure thin-client technology platform to create an enhanced, modern end-user experience.” Some of the key SAPPHIRE R5.1 new features and enhancements include: User-Centered Solution; New Clinical eForms; Enhanced Grid Data Entry; New Protocol Management; New Clinical Kit Management; Enhanced Study Management; Enhanced Quality Management; and, Embedded Validation Support; and, New Built-in configuration reporting tools. For details, visit http://www.labvantage.com.

Quality Systems International Introduces VersaLIMS

Quality Systems International (QSI) has introduced VersaLIMS.NET, a powerful yet economical, modular self-contained Laboratory Data Management System (LDMS) designed to deliver the level of data management required for small to medium sized labs. The VersaLIMS base system includes a PC, barcode reader, barcode printer and the core VersaLIMS software which provide sample and result management along with 30 pre-configured reports. Because it is based on the powerful and proven WinLIMS.NET technology, VersaLIMS.NET is easily scaled by adding functional modules and user licenses to provide additional functionality as a laboratory’s needs grow. For details, visit http://www.qsius.com.

New Agilent Lab Software Suite Unifies Instrument Data Systems, Electronic Lab Notebook and Data Archival

Agilent Technologies Inc. has introduced the OpenLAB software portfolio, designed as a better way for labs to efficiently capture, share, review and archive scientific data. "OpenLAB is scalable, open architecture, based on industry open standards, that enables customers to easily capture, analyze and share scientific data throughout the lab and across the enterprise,” said Tony Owen, Agilent senior manager, Software and Professional Services Marketing. “The new OpenLAB portfolio resolves a number of software challenges that affect labs of all sizes, and our open-systems approach means customers design the lab they want rather than having to work around their software systems.” Agilent OpenLAB consists of three integrated solutions: OpenLAB Chromatography Data System (CDS), OpenLAB Electronic Lab Notebook (ELN), and OpenLAB Enterprise Content Manager (ECM). The system is designed to grow with customers’ needs, from a small standalone analytical lab through a global network with hundreds of locations. Agilent OpenLAB is instrument vendor-neutral and provides easy migration paths from existing systems, protecting customers’ investments in existing systems. OpenLAB CDS integrates with OpenLAB ECM Intelligent Reporter, offering a new reporting approach to help customers quickly structure and see their results. OpenLAB ECM Intelligent Reporter facilitates analyzing information faster by automating final result assembly within the system, including data from multiple sources and multiple chromatography data systems. OpenLAB ECM Intelligent Reporter also allows for the automation of result review workflow; so it increases lab productivity and quality. With OpenLAB ELN, Agilent is making the efficiencies and security of the electronic lab notebook accessible to a wider range of labs, including those doing routine analytical work in fields such as hydrocarbon processing, environmental analysis, pharmaceutical food safety and forensics. Tightly integrated into the Agilent OpenLAB portfolio, OpenLAB ELN is designed to streamline workflows for chemists in analytical development and research. OpenLAB ECM is a secure, central repository enabling customers to capture, manage, share, archive and re-use any data in most file formats. Its Web-based user interface is easy to learn, and the retrieval function can perform meta data extraction from analytical and Microsoft Office files. Agilent OpenLAB is based on an open systems architecture that integrates disparate software systems. Designed to be scalable from workstation to enterprise, OpenLAB gives customers’ labs the ability to evolve as their needs change and grow. For details, visit http://www.agilent.com/chem/openlab.

LabWare Releases LabWare ELN

LabWare has announced its LabWare electronic laboratory notebook (ELN) solution, a key component of its enterprise laboratory platform strategy. LabWare ELN provides scientists and other laboratory personnel with the automation tools necessary to manage experiments, properly execute tasks, and to capture, preserve and safeguard intellectual property. LabWare ELN is an experiment and workflow driven software application designed to give the laboratory scientist a platform to electronically document their experiments, including relevant scientific content and observations, instrument results, and attachments such as spectra, chromatograms, and chemical structures where appropriate. LabWare ELN works seamlessly with LabWare LIMS, allowing any data within the LIMS to be accessible by the ELN and vice versa. Adding samples or tests to an ELN experiment is facilitated by simple-to-use mechanisms, such as drag and drop, bar-code scanning the samples into ELN, or selecting the samples from a list. For details, visit http://www.labware.com.

Waters Announces SDMS Vision Publisher

Waters has announced their SDMS Vision Publisher solution, an analytical electronic laboratory notebook (ELN) with an open, flexible design for both free-flow and process-driven workflows in discovery and QC laboratories. Key features include: Record Free-Flow Documentation Workflows; Ability to Create Structured Scientific Documents from Predefined Templates; Enhanced Search Capabilitiesthat enable users to query against single/multiple databases for document content, analytical data results, and administrative information; and, Enhancd Compliance that enable users to be certified to support the SAFE BioPharma digital identity and signature standard. An extended capability of NuGenesis SDMS, the new Vision Publisher streamline workflows that include LIMS, instrument software, and resource management systems by re-using scientific information captured and cataloged by the SDMS data repository. For details, visit http://www.waters.com.

Cerno Bioscience Announces MassWorks MS Software Support to Shimadzu LC/MS System

Cerno Bioscience has announced the expansion of its vendor file reading support for its MassWorks software with the addition of Shimadzu LC/MS Workstation mass spectrometry data files. This new addition allows users of Shimadzu LC/MS quadrupole systems running LCMS solutions to calibrate their data for accurate mass using Cerno’s MassWorks software. The software utilizes Cerno’s patented MSIntegrity calibration technology to improve mass accuracy results by up to 100X while achieving unparallel Spectral Accuracy on unit mass resolution mass spectrometers such as single and triple quadrupole systems. This allows users to perform accurate compound identification through elemental composition determination, a capability usually only available on more expensive, high resolution systems at significantly higher ownership cost. MassWorks significantly improves the quality of data and formula ID from any mass spectrometer from unit mass resolution instruments through to FTMS systems. MassWorks utilizes Cerno’s DirectRead technology to open and process the LCMSsolutions data from the native Shimadzu .lcd files. This eliminates the need for importing or exporting MS data to the clipboard or utilizing intermediate exchange formats. This saves time, reduces transcription errors, simplifies file management and saves substantial disk space. As DirectRead does not alter the original data, it assists compliance with common regulatory requirements such as GLP and the FDA’s 21 CFR Part 11. MassWorks also supports many other MS vendor files, including Agilent ChemStation, Thermo Scientific Xcalibur, Waters MassLynx, AB/Sciex Analyst, PerkinElmer TurboMass and Varian MSWorkstation. For details, visit: http://www.cernobioscience.com/products.html.

Abbott Completes Acquisition of STARLIMS Technologies

Abbott has completed its $123 million acquisition of STARLIMS Technologies Ltd., a leader in laboratory information management systems. The acquisition provides Abbott with leading products and expertise to build its position in laboratory informatics, an emerging and rapidly growing field focused on helping to manage the increasing amount of data generated in laboratories. STARLIMS's advanced web-based software applications help laboratories efficiently store, retrieve and analyze data and are designed for a wide variety of laboratory environments operating across a number of scientific, industrial and clinical disciplines. "STARLIMS gives us access to innovative technologies and technical expertise for our long-term strategy in laboratory informatics," said Edward L. Michael, executive vice president, diagnostics products, Abbott. "The acquisition enables us to provide a common informatics framework across all of our diagnostics businesses and, equally important, will help accelerate STARLIMS's growth strategy in the non-diagnostics market segments it currently serves." For details, visit http://www.starlims.com.

Thermo Fisher Scientific Adds The Winvale Group to Global Partner Alliance to Provide Informatics Solutions under GSA Schedule 70 Contract Procurement Process

Thermo Fisher Scientific Inc. has announced that The Winvale Group has become a member of its Informatics Global Partner Alliance. The Winvale Group, a total-solutions consultancy specializing in government procurement and the GSA Schedule program, will provide Thermo Fisher informatics solutions for federal, state and local governments operating under GSA Schedule 70. Headquartered in Washington, D.C., Winvale provides expertise to companies conducting business with federal, state and local governments. In addition to assisting with GSA Schedule 70, Winvale will ensure that Thermo Scientific informatics solutions, such as LIMS or CDS, can be acquired using federal stimulus dollars available to IT infrastructure projects sourced via GSA Schedule 70 to any service or research laboratory that fulfills the obligations of the state or local government. By adding Winvale to its Global Partner Alliance, Thermo Fisher continues its efforts to reach the critical audience of federal, state and local government laboratories that require IT solutions to manage a full range of scientific and laboratory research, from public health and safety laboratories to drinking water and public sanitation, environmental and state and federal research institutes. For details, visit http://www.thermo.com/informatics or http://www.winvale.com.

Thermo Fisher Scientific Equips the Scottish Metabolomics Facility with Cutting-Edge Technology to Advance the Field of Metabolomics

Thermo Fisher Scientific Inc. is providing the Scottish Metabolomics Facility (ScotMet) with cutting-edge technology to advance the field of metabolomics. ScotMet is funded by the Scottish Universities Life Science Alliance (SULSA) and is a state-of-the-art facility run jointly by the Universities of Glasgow and Strathclyde. The facility combines mass spectrometry, separations technology and bioinformatics. ScotMet, which already used Thermo Fisher instruments, will now install four Thermo Scientific mass spectrometers, including an LTQ Orbitrap Velos with ETD and FAIMS source, a DSQ-II GC/MS and two Exactive LC/MS benchtop instruments. The superior mass accuracy and sensitivity of the LTQ Orbitrap Velos, equipped with the multiple fragmentation modes available (CID, HCD, ETD and PQD), will allow researchers to rapidly accelerate their research. In addition, for high throughput metabolite screening experiments, the fast polarity switching of the Exactive allows effective data collection in positive and negative modes. For details, visit http://www.thermo.com/metabolomics.

Agilent Makes Fish DNA ID Fast, Simple, Accurate for Routine Testing of Seafood to Verify Species and Labeling

Agilent Technologies has announced a system that speeds and simplifies the use of DNA to identify fish species in food products, making this highly-accurate technique feasible for routine verification of seafood labeling and detecting. The Agilent Fish Species Identification method matches samples to a species DNA database. The system uses an Agilent DNA Fish Species ID Ensemble with an Agilent 2100 Bioanalyzer lab-on-a-chip system, and specialized RFLP Decoder Software. The DNA analysis method is based on polymerase chain reaction-restriction fragment length polymorphism (PCRRFLP). The method is far more accurate and robust than existing protein-based tests, and also reduces the time needed to confirm species in food from days to hours. Routine DNA analysis now becomes feasible for use by seafood processors, distributors, large retailers, public interest organizations and government agencies. For details, visit http://www.agilent.com.

Optibrium Showcases StarVue at ACS Spring 2010

Optibrium, a provider of software solutions for drug discovery, will be showcasing StarVue on booth #121 at 2010 Spring ACS National Meeting and Exposition, March 21-25, San Francisco, CA, USA. Optibrium's StarVue is a free desktop application that enables scientists to quickly and conveniently view compound structures and data. The new application eliminates the need to use expensive plug-ins for Microsoft Excel to examine, sort and search chemistry data sets. Visitors to Optibrium's booth #121 at ACS Spring 2010 will receive a copy of StarVue, allowing users to explore their compound data in a new way. This free and easy-to-use desktop application is specifically designed for scientists who want a simple way to load a set of molecule structures and easily browse through the data. StarVue allows users to simply load, scroll though, sort and manage data in a new way, providing the ability to view and manipulate chemical structures. For details, visit http://www.optibrium.com/starvue.

APP Pharmaceuticals Goes Live with Novatek's Environmental Monitoring LIMS

APP Pharmaceuticals has chosen Novatek International for automating its environmental monitoring processes at multiple locations within the USA and went live with the Nova-EM software in March 2010. APP Pharmaceuticals began its process with a proof of concept focusing on ease of use, system setup and configuration as well as completion of the installation and validation within the pre-established timeline and budget. In particular, APP Pharmaceuticals needed a software solution to address all of its requirements and offered good project management that could be expedited and fall within the budget. Novatek differentiates itself by offering process-based off the shelf software solutions that meet at least 95% of user requirements readily thus providing a shorter implementation and deployment time allowing clients to go-live sooner. With the largest group of environmental monitoring users in the world NOVA-EM is a conglomerate of hundreds of user requirements and incorporates the in-depth knowledge of expert microbiologists and environmental monitoring specialists. Thus Novatek was able to easily map APP pharmaceuticals' standard operating procedures to Novatek's environmental monitoring software. The positive outcome of the proof of concept provided APP Pharmaceuticals with the confidence that the environmental monitoring software would live up to the claims made by Novatek International. "We are delighted to welcome APP Pharmaceuticals to the ranks of hundreds of other satisfied customers around the globe," said Novatek International President, Parsa Famili. For details, visit http://www.ntint.com.

Symbion Systems Announces Integration of its Process Analytical Technology Software with Infometrix’ Chemometrics Technology

Symbion Systems, Inc., a leader in providing analytical instrument control, analysis, and connectivity software, has announced the availability of its SCI-IP01 software driver to interface with the Infometrix line of chemometrics products. The new driver facilitates the integration of chemometric calibrations developed using Infometrix’ Pirouette multivariate analysis program into methods developed using Symbion-DX and RX Process Analytical Technology (PAT) software. The combination of the Symbion and Infometrix Software products provides a comprehensive capability for process analytical methods development and on-line deployment. Pharmaceutical industries have long struggled with the real-time data acquisition of in-line, at-line, on-line and off-line data. Alignment of all these data in a consistent and structured way is important in order to predict product quality based on Multivariate Models. Integration of Symbion solutions with the Infometrix’ technology provides users all of the predictive and diagnostic tools found in Pirouette configured in a way that allows real time process monitoring. Symbion-DX and RX provides standardized platforms for controlling a wide range of spectrometers and other analytical instruments. In addition, they feature extensive data manipulation and application development capabilities as well as the ability to communicate with numerous third party programs and enterprise-wide data systems. In short, the Symbion programs streamline the development of comprehensive analytical methods encompassing instrument and sample system control, data analysis, process trending, database archiving, and reporting to enterprise-wide data systems. Each method is permanently stored in the Symbion data base and is under full version control, compliant with 21 CFR Pat 11. Once validated, a method can be recalled from the data base and downloaded for deployment at multiple instrumentation locations. For details, visit http://www.gosymbion.com.

Agilent Technologies Facilitates Third-Party Software Control for Agilent LC Systems

Agilent Technologies Inc. has introduced the Instrument Control Framework (ICF), a software component making it faster and easier for third-party software to enable and control Agilent liquid chromatography (LC) systems in chromatographic data systems or workstations. Based on new standard instrument drivers from Agilent, ICF eliminates much of the delay and effort associated with software developers using low-level instrument control codes to write their own native drivers. Agilent is providing ICF to software developers at no cost. Agilent’s ICF contains Agilent 1200 Series LC RC.NET instrument drivers and provides a simple programming interface for third-party software connectivity. The third-party simply develops an adaptor from their own software to ICF to gain full control of current, future and some older Agilent LCs, with no need to write additional instrument control code. For details, visit http://www.agilent.com.

Alpha MOS Releases AroChemBase Chemical & Sensory Database

Alpha MOS has developed a new database for aroma & chemical characterization by gas chromatography analysis. The AroChemBase library uses Kovats Index as a reference method. It includes 2,900 compounds of which 1,400 with sensory attributes, with chemical information (Name, formula, CAS number, molecular weight, Retention Index) available for several columns (Methylpolysiloxane, Methyl 5% Phenyl Polysiloxane, Cyanopropylphenyl 14% Dimethyl Polysiloxane 86%, Polyethylene Glycol). Used with 2-column GC-based Electronic Nose or GC system, it allows a dual column identification and ranking. Rapid characterization of compounds, fast sample screening. For a selected peak on a chromatogram, the library proposes a list of possible compounds. To facilitate identification, the compounds are sorted based on a unique recognition accuracy index. This index is based on the comparison of measured parameters (retention time, peak area on 1 or 2 columns) and theoretical ones. The higher the index, the higher the probability of correspondance. The specificity of this library is to provide the sensory attributes linked to a chemical compound, which makes it particularly suitable for all quality control or R&D applications with sensory considerations. For details, visit http://www/alpha-mos.com.

Autoscribe Releases New LIMS Newsletter

Autoscribe is pleased to announce the availability of Issue 1 of Matrix Matters, a newsletter dedicated to the LIMS market. The first issue contains article extracts relating to both system implementation and system configuration supplemented by details of the “How to buy a LIMS” guide. Life science topics include biobanking, radio-pharmacy laboratory management and PET (Positron Emission Tomography) LIMS. There is also an extract from a case study involving the Roy Castle Lung Cancer Foundation. Matrix Gemini benefits are discussed and information on recent customer surveys, conducted by Autoscribe, is also included. Full articles on all of these topics, and much more, will be available using a response form supplied with the newsletter. For details, visit http://www.autoscribelims.com.

Symbion Systems Releases Technical Note Describing a Software Approach to Accelerating Process Analyzer Deployment

Symbion Systems, Inc., a leader in providing analytical instrument control, analysis, and connectivity software, has announced the availability of its new Technical Note, SN-504. This is a preprint of a paper by Drs. W. M. Doyle and M. A. Power prepared for delivery at the ISA (International Society of Automation) Analyzer Division Spring meeting. The paper describes a software approach designed to accelerate process analytical technology (PAT) development and deployment by standardizing the interactions with diverse analytical instruments, sampling systems, chemometric (multivariate analysis) programs, and enterprise data systems and by integrating all required functionality at the analyzer level. In addition to the required control and data analysis functions, the system provides local displays in various formats, including statistical information and real-time trend plots, as well as database storage, alarms, and remote communications. The package can be implemented on a standard PC or integrated into a dedicated process analytical “appliance” for locked-down deployment. The result of analytical integration at the analyzer (or process) level is to create an “Autonomous Analyzer System” which can be developed, validated, and deployed independently of all other systems. When properly locked-down, it becomes, in effect, a series of dedicated smart sensors. Its primary function is to output predictions of process variables measured at predetermined locations within a chemical process. In addition, raw data can be stored locally and transferred to the plant network as required. For details, visit http://www.symbion.com.

FDA Realigns New Drug Office to Improve Review Process

Nearly 220 INDs are being moved during the week of March 15, 2010 from the Office of New Drugs’ (OND) Division of Anesthesia and Analgesia Products to the Division of Pulmonary and Allergy Products as part of an OND realignment. Additionally, 61 NDAs and 13 BLAs will shift to the newly named division beginning the following week. The FDA is reorganizing CDER’s OND to better distribute INDs, NDAs and BLAs across review divisions, the agency said. For details, visit http://www.fda.gov.

Congress May Consider Fees for Reinspections by FDA

Federal budget pressures, coupled with a need to increase the FDA’s international presence, may give Congress the impetus to pass a new drugmaker user fee to cover the costs of reinspections. A reinspection fee is included in the FDA Food Safety Modernization Act, S. 510, which was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee last December. No date has been set to bring the bill to a full Senate vote. Although the fee is not specifically aimed at drugmakers, industry fears it could open the door for reinspection fees for all FDA-regulated facilities. For details, visit http://www.fda.gov.

FDA Final Guidance Outlines Procedures for Viral Vaccine Makers

Manufacturers of viral vaccines can more easily use new cell substrates and other materials to make vaccines now that the FDA has issued a final guidance on developing and testing the cells, viral seeds and other biological materials. Currently, all licensed influenza vaccines are produced in chicken eggs, a lengthy process. The guidance finalizes a draft document issued in 2006 and supplements documents from the International Conference on Harmonisation on viral vaccines. For details, visit http://www.fda.gov.

FDA Outlines Process to Demonstrate Product Sterilization Control

Drugmakers can meet sterility requirements for their products — and avoid conducting a formal sterility test — if they can demonstrate control of the sterilization process through parametric release. Parametric release is a sterility assurance program based on an assessment of an applicant’s proposed critical process parameters and how they are controlled, the FDA says in a draft guidance. For details, visit http://www.fda.gov.

Drugmakers Ask FDA to Reconsider Social Media Policy for Drug Risks

Industry is asking the FDA to reconsider its apparent rejection of a “one-click” policy for presenting drug safety information in some online advertisements, which prompted 14 untitled letters a year ago. Clicking on a single hyperlink to find required product safety information not included in certain brief online messages is reasonable, the Biotechnology Industry Organization says in comments on manufacturers’ and consumers’ use of social media to communicate about drugs. For details, visit http://www.fda.gov.

FDA Issues First Draft Guidance on Noninferiority Trials

The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs. NI trials compare a new drug with a proven drug to determine whether the new drug is less effective by an unacceptable margin. The major focus of the guidance is determining the NI margin, which must be estimated based on past performance of the active control drug and by comparing other test conditions to the current environment, according to the draft guidance. Comments are due May 30. For details, visit http://www.fda.gov.

Final REMS Guidance May Be Delayed Due to Staffing Issues

Drug and biologics makers may have to wait longer for a final guidance on risk evaluation and mitigation strategies (REMS) because CDER staff developing the recommendations also must review all proposed REMS from drugmakers, slowing the process significantly. CDER approved new REMS for 98 products over a period of almost two years, 28 of which included more than a medication guide, Kathleen Frost, associate director for regulatory affairs at CDER’s Office of Surveillance and Epidemiology, said at a Food and Drug Law Institute conference. For details, visit http;//www.fda.gov.

What's New - Right Now The following is a wrap-up of news of interest during the month of March 2010

What's New - Right Now
The following is a wrap-up of news of interest during the month of March 2010