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# CDER Policy on ANDA Filing Reviews
- URL: https://www.fdaweb.com/cder-policy-on-anda-filing-reviews/
- Published: 2017-09-01T12:00:00.000Z
- Updated: 2026-09-14T22:46:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139533

CDER has published a new Manual of Policies and Procedures on “[Filing Review of Abbreviated New Drug Applications](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwOTAxLjc3NjIwMzgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDkwMS43NzYyMDM4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDQ1NjM3JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM574493.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery).” The document outlines policies and procedures for conducting an ANDA filing review by the Office of Generic Drugs Division of Filing Review (DFR). It includes DFR reviewer responsibilities when determining whether an ANDA submission is sufficiently complete and may be received for review. The document also contains DFR’s current ANDA Filing Checklist, which is a general tool designed to assist the reviewer in assessing the information and data contained in the submission.