USFDA Updates MAPP for Facility CR Major to CR Minor

FDA has updated MAPP for assessment of requests for reclassification of facility-based major complete response (CR) letter amendments. On December 21, FDA published a revised CDER manual of policies and procedures (MAPP) to assess requests for reclassification of facility-based major complete response (CR) letter amendments for ANDAs and Prior Approval Supplements (PAS). The MAPP is updated to include information on how to assess the impact of a facility withdrawal on the reclassification request.

Drugmakers can request the reclassification of a facility-based “major” CR letter amendment to a “minor” amendment, without being reinspected if they meet certain conditions. One major concern of the generic industry is the lengthy delays for a reinspection after getting an official action indicted (OAI) on a former inspection. The MAPP elaborates the procedures for OPQ and OGD to more easily resolve these issues.

FDA will review a request for reclassification from major to minor if the following conditions are met:

• The CR letter was issued on or after 1 October 2022, the GDUFA III implementation date;
• The reclassification request is submitted with a CR letter response amendment in the submission;
• The facility issue is the only major deficiency;
• The CR letter’s major amendment classification is based on an observation from a surveillance inspection
• The submission includes a VAI or NAI letter issued subsequent to the OAI classification letter OR theOAI facility is withdrawn along with a statement that the facility did not generate data to support a regulatory action (e.g., exhibit batches, stability batches)

FDA will deny a request for reclassification request from major to minor if:

• The facility deficiency was not based on a surveillance inspection;
• The facility deficiency has not been adequately resolved for the subject drug;
• The submission does into include the VAI or the NAI GMP classification letter issued by FDA.
• The facility or facilities that are the subject of the major deficiency are being withdrawn, but they had generated data which can no longer serve as the primary basis of approval

MAPP 5021.5 Rev. 1 – Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests