The Food and Drug Administration (FDA) has released draft guidance for industry entitled “Submission of Summary Bioequivalence Data for ANDAs.” The draft guidance is intended to assist ANDA applicants in complying with new requirements in a January 2009 final rule that requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval. The guidance is applicable to BE studies conducted during both preapproval and postapproval periods. FDA is accepting comments on the draft guidance until July 16, 2009.