MAPP on ANDA Facility Deficiency Reclassifiaction

FDA has published a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests. The document describes the policies used in the Office of Pharmaceutical Quality, the Office of Compliance, and the Office of Generic Drugs for assessing requests for reclassification of facility-based major complete response (CR) letter amendments for original ANDAs and associated prior approval supplements. “This MAPP applies to reclassification requests received as part of a single amendment that consists of both a reclassification request for facility-based deficiencies and a response to a CR letter in which the only major deficiency(ies) in the CR letter resulted from a facility inspection(s) or assessment,” the agency says. The MAPP was developed as one of the enhancements to the user fee program to make the assessment cycle more efficient.