FDA Guidance: Bioequivalence (BE) Recommendations and Drug Clinical Trials
The FDA has announced the availability of additional draft and revised draft product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). FDA will accept comments on the recommendations until December 4, 2008. Separately, the FDA has released draft guidance entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The document, which discusses the types of nonclinical studies and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals, is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. The FDA is requesting comments on the draft guidance by October 20, 2008.
