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

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S. drug safety system will require an expanded workforce in all areas, not just epidemiology. 4), what their competencies should be, what the mix of staffing should be, and what it will take to educate and train these new personnel, including the required academic infrastructure. • The need for evidence—Benefit–risk data from preclinical, clinical, and postmarket spontaneous reports are all limited with respect to their This section is based on the presentation of Dr. Tilson. 28 CHALLENGES FOR THE FDA predictive value and generalizability.

Gaining a better understanding of the safety profile of a drug and being able to discriminate more precisely among drugs within the same class before clinical testing begins would strengthen the drug safety system before a drug ever reaches the market. Postmarket safety is dependent upon a continuum of knowledge, including understanding of a drug’s mechanism of action, as well as the information gained from clinical trials and epidemiological studies. , 2007). Key among these recommendations was the advancement of current scientific opportunities through the Critical Path Initiative (see below) in order to create a stronger, safer, science-based FDA.

Number of New Molecular Entities Approved STRENGTHENING THE SCIENTIFIC BASE OF THE AGENCY 23 60 50 40 30 20 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Year FIGURE 3-1 Number of new drugs approved in the last 10 years (1996–2006). SOURCE: Adapted by permission from Macmillan Publishers Ltd: Nature Reviews Drug Discovery (Owens, 2006 drug approvals: finding the niche), copyright 2007. eps R01076 als designed to support new indications were able to detect safety signals for all three of these drugs.

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