Bioequivalence guidance accessibility
FDA releases draft guidance regarding the agency's plans to make product-specific, bioequivalence study design guidance available to the public on FDA's Web site. Currently, ANDA applicants must request guidance from the agency and wait for a response. The agency is seeking public comments for product-specific bioequivalence recommendations. FDA's Office of Generic Drugs has touted this long-awaited guidance as a means to reduce correspondence (1"The Pink Sheet" March 26, 2007, p. 14)...
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Brand firms are weighing in on product-specific draft guidance issued by FDA, which the agency hopes will allow generic drug firms to design bioequivalence studies for their ANDAs without having to consult with the Office of Generic Drugs (1"The Pink Sheet" June 11, 2007, In Brief). The draft guidances can be found on 2FDA's Web site
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