WASHINGTON, July 29 -- Food and Drug Administration has issued a notice called: Product-Specific Guidances; Revised Draft Guidances for Industry; Availability.
The notice was published in the Federal Register on July 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Registerof June 11, 2010, FDA announced the availability of a guidance for industry entitled "B...