Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper
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David M. Coctbetto, PbD US Regulatory Affairs, GlaxoSmithKline. Research Triangle Park. North Carolina Tbomas H. Hassall, MS, RPb Global Pharmaceutical Regulatory Affairs, Abbott Laboratories. Rockville, Maryland Linda Carter Global Regulatory Policy and
Intelligence. Johnson S. Johnson. Rockville, Maryland
Jobn R. Cutt, PbD Drug Regulatory Atairs. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey Tar yn Rogalski-Salter, PbD Regulatory Policy, Merck Research Laboratories. North Wales. Pennsylvania Catbie Scbumaker AstraZeneca, Rockville, Maryland Jeniifer 1. Stotka, MD U S Regulatory Affairs, Eli Lilly and Company, Indianapolis. Indiana
Key Words GRMPs; Best practices; Advisory Committee CorrespondenceAddress David M. Cocchetto, PhD. GlaxoSmithKline. 5 Moore Drive, Research Triangle Park, NC 27709 (e-mail: david. m.cocchetto@ GSK.com).
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Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper Advisory Committees to the Food and Dtug Administmtion provideFDA with expert advice on
medical and scientific topics relevant to FDA's responsibility to protect and promote the public health. The history and experience with Advisory Committees (since authorization in f e d d law in 1972)provides a rich background to infm a review of best pmctices. The fdlowing best pmctices for the Advisory Committee process are noteworthy: Rde definition: A shared understanding of the rdes of all participants in the Advisory Committee process hdps tofosterpmductive meetings andfacilitates prompt resdution of potentially contentious iwcs. Tmnsparency: FDA and sponsor should operate with tmnsparency in bidirectional sharing of infmation and perspectives before, during, and after a produd-specijic Advisory Committee meeting. Regulatory knowkedge: Advisoly Committee members. special government employees. consultants,
INTRODUCTION The US Food and Drug Administration (FDA) is responsible for "protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation" (1). The FDA is also responsible for "advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health" (1). FDA's mission demands that employees in FDA's reviewing divisions possess the medical, scientific,and statistical expertise needed to execute the agency's mission. In addition to intra-
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and sponsors must all have a fundamental knowledge of the regulatory principles gwerning the Advisory Committee process, as well as devdopment and tzgistmtbn of drug and bidogic promcds. Access andfocus: FDA has an ongoing needfor access to external medid and scientific cxperts to augment the agency's internal experts. Consultation with Advisory Gnnmittecs should be focused on situat
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