Reassignment of Bioequivalence Reviews MANUAL of POLICIES and PROCEDURES Fda Form

Instructions and help about Reassignment Of Bioequivalence Reviews MANUAL OF POLICIES AND PROCEDURES Fda

thank you for the introduction today i will be talking with you about bioequivalence regulatory requirements looking at some relevant regulations and how these regulations relate to product specific guidances i will also discuss the availability of alternative approaches to recommendations in product specific guidances and the pathways that applicants can use to discuss alternative approaches with fda i will then describe in vivo and in vitro bioequivalence testing requirements and recommendations again looking at some of the relevant regulations and then describe how fda revises product specific guidances and how those revisions are consistent with the regulations final regulations published in the federal register are collected in the code of federal regulations the cfr fda's portion of the cfr interprets the federal food drug and cosmetic act and related statutes section 21 of the cfr contains most of the regulations pertaining to drugs regulations such as the regulations included i