Challenges for the FDA: The Future of Drug Safety, Workshop by Leslie A. Pray, Sally Robinson

By Leslie A. Pray, Sally Robinson

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Extra resources for Challenges for the FDA: The Future of Drug Safety, Workshop Summary (Forum on Drug Discovery, Development, and Translation)

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Once pilot programs have been assessed, the agency will be better equipped to make that decision. Further, he emphasized that whoever has responsibility for sign-off, the postmarket review and assessment, as well as any revisions to labeling, must involve clinical judgment and understanding of both the risks and benefits of the therapy. Dr. Unger expressed his impression that there is not a great deal of clinical experience within OSE, and that OSE would need to expand its resources to include clinicians who understand both risk and benefit.

Therefore, Dr. McClellan suggested that the acquisition of better data and the implementation of a systematic strategy for analysis will require additional support for postmarket surveillance, the development of a comprehensive implementation plan, and effective public–private collaboration to carry it out. Dr. ” The consortium could be an important component of a national active surveillance system that would include other data sources. As Dr. Tilson noted, the CERTs were created under congressional mandate and have robust processes that already make them good hosts for a public–private partnership.

2 billion. eps billion. SOURCE: Coalition for a Stronger FDA, 2007. committees are unsympathetic to the agency’s drug safety mission, but because the majority of resources are consumed by the agricultural sector. ” Industry User Fees Mary Pendergast, President, Pendergast Consulting, asserted that since the authorization of PDUFA in 1992, Congress has increasingly relied on user fees rather than congressional appropriations to fund the ADDRESSING THE FDA’S RESOURCE CHALLENGES 17 FDA, a situation that contrasts with the funding provided to CDC and NIH.

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