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# PAS Expedited Review MAPP Out
- URL: https://www.fdaweb.com/pas-expedited-review-mapp-out/
- Published: 2018-04-27T12:00:00.000Z
- Updated: 2026-09-15T00:01:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141316

CDER has issued a [Manual of Policies and Procedures](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM079834.pdf?ref=fdaweb.com) outlining the policies of the Office of Pharmaceutical Quality (OPQ) for granting or denying a request for an expedited review for NDA and BLA prior approval supplements that **(1)** involve chemistry, manufacturing, and controls changes and **(2)** are managed by OPQ. The MAPP specifies both the criteria OPQ uses to make an expedited review designation and the roles and responsibilities of the OPQ quality assessment team members for making this designation.