This post was written by Erin Janssen.

The FDA has released additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new BE recommendations were developed using the process described by FDA in a June 11, 2010 notice. The public is encouraged to submit comments on the new recommendations by August 13, 2012.