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# Generic Drug Review Prioritization MAPP
- URL: https://www.fdaweb.com/generic-drug-review-prioritization-mapp/
- Published: 2017-11-09T12:00:00.000Z
- Updated: 2026-09-14T23:01:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140097

CDER has issued a Manual of Policies and Procedures (MAPP) describing how the review of original ANDAs, ANDA amendments, and ANDA supplements will be prioritized within the Office of Generic Drugs and the Office of Pharmaceutical Quality. The [MAPP](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407849.pdf?ref=fdaweb.com) establishes public health priorities (prioritization factors) that may qualify an original ANDA, amendment, or supplement for a priority review. The factors are: 

- submissions containing certain patent certifications and exclusivity statements;
- submissions related to drug shortages;
- submissions subject to special review programs such as the President’s Emergency Plan for AIDS relief;
- submissions related to public health emergencies;
- submissions related to certain government purchasing programs;
- submissions subject to mandatory mandates or other legal requirements;
- supplements for which a priority review is requested for public health reasons when a delay would cause extraordinary hardship on the applicant;
- submissions for “sole source” drug products.