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Bioequivalence guidance accessibility

Executive Summary

FDA releases draft guidance regarding the agency's plans to make product-specific, bioequivalence study design guidance available to the public on FDA's Web site.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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