FDA Issues New MAPP on Product Development, Pre-Submission Meetings for ANDAs

The FDA laid out a three-stage process for how the agency will handle product development and pre-submission meetings for ANDAs, in a new Manual of Policies and Procedures (MAPP).

A prospective applicant can request a meeting using the CDER Next Gen Collaboration Portal or by contacting the Office of Generic Drugs via email. If a meeting request is granted, the agency’s project manager will tell the applicant within 14 days.

The agency will grant a meeting if it concerns a product for which there is no product-specific guidance or an “alternative equivalence evaluation.” Depending on resources, the agency may grant a product development meeting if it involves topics that the agency feels would significantly improve ANDA reviews.