FDA is considering developing a guidance on the use of epidemiological data in order to facilitate post-marketing surveillance. The document would advise industry on the analysis of large safety databases. The expansion of funding for post-market drug surveillance activities is under discussion as part of the fourth renewal of the Prescription Drug User Fee Act next year (1"The Pink Sheet" Nov. 21, 2005, p. 3)...
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FDA is emphasizing the difficulties of industry requested meetings in its early public discussion of the 2007 Prescription Drug User Fee Act reauthorization
In this week's podcast edition of Five Must-Know Things: a preview of the CTAD Alzheimer’s meeting; US myeloma drug withdrawal puts pressure on GSK; UniQure/CSL's gene therapy sets new US price record; new leadership at Teva; and Merck’s Frazier cautions against profit maximization.
Attention must be paid when withdrawal is for NDA approved in 1948 for brand synonymous with nonprescription pain relief, Bufferin. Even when FDA’s decision amounts to NDA database recordkeeping, withdrawal of application demands notice in US OTC space.