FDA Issues Draft Guidances for Online Access of Bioequivalence Studies for Generic Drugs

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site rather than having to request this information from the agency and wait for the agency to respond, as has been the case in the past. FDA believes that making this information available on the Internet will streamline the guidance process and provide an opportunity for the public to consider and comment on BE study recommendations for specific drug products.

Previously, the Office of Generic Drugs provided guidance on how to design BE studies for specific products only when asked for assistance by interested parties. In 2000, to help address this growing problem, FDA issued the guidance Bioavailability and Bioequivalence Studies for Orally Administered Drug Products--General Considerations, which describes general recommendations for demonstrating bioequivalence. FDA said that although these general recommendations were helpful, many parties continued to seek assistance from the agency in designing their product-specific BE studies, as certain drug products may raise BE issues not addressed in a more general guidance.

To streamline the process for making guidances available to the public on how to design product-specific BE studies, FDA proposes to develop and post product-specific BE recommendations in draft on the Internet on the Center for Drug Evaluation and Research’s (CDER) guidance page. Newly posted draft and final BE recommendations will be announced in the New/Revised/Withdrawn list, which is posted monthly on the CDER guidance page. FDA will issue a notice in the Federal Register announcing the availability on the FDA Web site of new product-specific draft and final BE recommendations. Comments on product-specific BE recommendations will be considered in developing final BE recommendations.

Notice of the draft guidance, Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products appeared in the May 31, 2007 Federal Register. Comments on the draft guidance are due by Aug. 29, 2007.

FDA issued a second draft guidance, Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availabilityalso in the May 31 Federal Register. This draft guidance lists approximately 200 active ingredients for which BE study recommendations are now available and may be found at www.fda.gov/CDER/guidance/bioequivalence/default.htm.

The deadline for submitting comments on this draft guidance is Sept. 28, 2007.