The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following up on reclassification requests following complete response letters (CRLs) to generic drug applications.
MAPP 5021.5, published on 12 June 2023, describes the policies used in the Office of Pharmaceutical Quality (OPQ), the Office of Compliance (OC) and the Office of Generic Drugs (OGD) to assess requests for reclassifying facility-based major CRLs from major to minor requests for original abbreviated new drug applications (ANDAs) and prior approval supplements (PASs).
The Generic Drug User Fee Amendments of 2022 (GDUFA III) allows drugmakers to request the reclassification of a facility-based “major” CRL amendment to a “minor” amendment, without being reinspected if they meet certain conditions…
