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# Amino Acid Polymer Product Assessment
- URL: https://www.fdaweb.com/amino-acid-polymer-product-assessment/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:50:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143012

CDER has issued a Manual of Policies and Procedures (MAPP) to describe how the responsibility for the integrated quality assessment of products containing drug substances composed of amino acid polymers will be divided among the Office of New Drug Products, Office of Lifecycle Drug Products, Office of Process and Facilities, and the Office of Biotechnology Products in the Office of Pharmaceutical Quality.

The [document](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM628110.pdf?ref=fdaweb.com) says the MAPP serves as a guide for the Office of New Drugs and the Office of Pharmaceutical Quality’s Office of Program and Regulatory Operations to direct submissions and manage other interactions regarding the quality assessment of products containing drug substances composed of amino acid polymers.

The MAPP procedures apply to the quality assessment performed by the Office of Pharmaceutical Quality for all original INDs, IND amendments, NDAs, original BLAs, NDA and BLA amendments, and supplements to approved NDAs and BLAs for products containing drug substances composed of amino acid polymers. It does not apply to ANDAs and also does not apply to products containing amino acid polymers solely as excipients.