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# CDER Policy on Priority ANDA Reviews
- URL: https://www.fdaweb.com/cder-policy-on-priority-anda-reviews/
- Published: 2016-03-11T12:00:00.000Z
- Updated: 2026-09-15T02:43:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135054

CDER has posted a revised internal [policy document](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407849.pdf?ref=fdaweb.com) on “Prioritization of the Review of Original ANDAs, Amendments, and Supplements” that describes the priority certain generic drug applications receive during the review process. According to the document, the following types of submissions receive the highest priority reviews:

> **1.** Submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12), such as a potential first generic products for which there are no blocking patents or exclusivities on the reference-listed drug.  
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> **2.** Submissions that could help mitigate or resolve a drug shortage and prevent future shortages.  
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> **3.** Submissions that are subject to special review programs such as the president’s Emergency Plan for AIDS Relief  
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> **4.** Submissions that could help address a public health emergency declared by the secretary of the Department of Health and Human Services.  
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> **5.** Submissions related to certain government purchasing programs   
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> **6.** Submissions subject to federal or state mandates or other legal or regulatory actions.