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USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs

Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13 Quality Assessment for Products in Expedited Programs, which will go into effect on December 7, 2022.

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures which are required by law and made available to the public to make CDER a more transparent organization. Check out the current list of MAPP by clicking this LINK.

Policies and procedures outlined in this MAPP are used at the Office of Pharmaceutical Quality (OPQ) to facilitate and expedite the development, submission, assessment, and marketing approval of new drug applications (NDAs) and biologics license applications (BLAs) for products that address unmet medical needs in the treatment of serious or life-threatening conditions.

The purpose of this document is to fulfill the Prescription Drug User Fee Act (PDUFA) VII commitment letter's CMC readiness commitments, including the publication of a MAPP for addressing CMC challenges for products regulated by the Center for Drug Evaluation and Research (CDER) with accelerated clinical development timelines. Additionally, this document provides support for the CMC readiness pilot program outlined in PDUFA VII.

This MAPP applies to OPQ’s facilitation of CMC development for breakthrough therapy products, fast-track products, and products included in the CMC readiness pilot.

Click this LINK to have detailed information on policies and procedures in this MAPP.


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