2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug applications, and supplements; the definitions of bioavailability and bioequivalence; and the types of in vitro and in vivo studies that are appropriate to measure bioavailability and establish bioequivalence are set forth in part 320. 

This guidance provides recommendations on how to meet provisions of part 320 for all drug products.

Read FDA guidance document