FDA releases bold plan
The US Food and Drug Administration (FDA; Rockville, MD) Commissioner Mark McClellan at the end of January announced bold plans for speeding product reviews and approvals, including those for generic drugs, and indicated that these reforms will help to reduce costs for developing those products. The agency-wide initiative contains three major components: avoiding multiple cycles of FDA review through early communication; adopting a quality systems approach to medical product reviews; and providing product developers with up-to-date guidance for particular diseases and emerging technologies. These plans are detailed in a report, “Improving Innovation in Medical Technology: Beyond 2002” that also summarizes the overall review performance of the agency during 2002; for example, approval times increased for some biologic new molecular entity applications that had received priority review status, whereas those times decreased for some standard biologic applications. As part of this initiative, FDA promises to “clarify regulatory pathways...in three emerging areas of technology: cell and gene therapy, pharmacogenomics, and novel drug delivery systems.” McClellan also pointedly reached out to generic drug manufacturers in January, calling for more research in characterizing “complex products” in terms of “pharmaceutical equivalence,” including “such drugs as insulin and human growth hormone [and other] recombinant drugs....” JLF
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