The US Food and Drug Administration does not have the luxury ofcoasting, Bernard Schwetz, FDA Acting Principal Deputy Commissioner, has told the US Food and Drug Law Institute's annual Educational Conference. Its top priorities include upholding the letter and spirit of the FDA Modernization Act and the ongoing challenge of maintaining its strong science base, he said, noting that the latter is the foundation for FDA decisions in setting policy and supporting legal actions, research and product review, as well as helping maintain relationships with overseas counterparts.
Proteomics and genomics research, stem cell-derived products and increasing gene therapy trials have again shown that the FDA must have a critical mass of in-house specialists who are current with technology advances, and the resources to support these scientists, said Dr Schwetz. To deal with recent challenges, the agency has set up a new Office of Human Research Trials (see also page 13).
The FDA has mostly exceeded its Prescription Drug User Fee Act performance goals, he said. Last year, it reviewed over 17,000 marketing applications for drugs, biologics and devices, and approved 97%. 160 applications were for products never marketed in any form in the USA. Discussing concerns that the rise in product approvals has led to more withdrawals, he stressed that the latter are up in terms of absolute numbers but not in the percentage of products withdrawn.
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