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# CDER Biopharmaceutics Council MAPP
- URL: https://www.fdaweb.com/cder-biopharmaceutics-council-mapp/
- Published: 2019-04-24T12:00:00.000Z
- Updated: 2026-09-15T01:22:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143949

CDER has issued a Manual of Policies and Procedures for its new Biopharmaceutics Council, a multi-disciplinary and cross-organizational panel providing senior management support on development and application of policies, practices, and recommendations related to biopharmaceutics in drug review processes, as well as to other CDER programs, as appropriate. The [MAPP](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM636587.pdf?ref=fdaweb.com) defines biopharmaceutics as “a broad-based scientific discipline that studies the effect and interplay of the physicochemical properties of a drug, its dosage form, and the intended route of administration on the rate and extent of the drug’s absorption.”

CDER currently has multiple offices and programs addressing various biopharmaceutics issues, the MAPP says, and coordination is needed to foster collaboration and promote consistent and integrated biopharmaceutics-related activities throughout the Center.

The document says the council will meet regularly to consider biopharmaceutics-related issues that are complex or precedent-setting and require senior management input. Issues pertaining to biopharmaceutics may be submitted to the council by any CDER staff member. The document contains criteria that would generally apply for an issue to be considered by the council.