FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PRODUCT-SPECIFIC GUIDANCES; DRAFT AND REVISED DRAFT GUIDANCES FOR INDUSTRY; AVAILABILITY

WASHINGTON, Oct. 2 -- Food and Drug Administration has issued a notice called: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability.

The notice was published in the Federal Register on Oct. 2 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and 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 f...