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Product safetyFDAUnited StatesImports

Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement

21 September 2026

In plain English

FDA announces year five of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program to support expedited CMC development for IND products under CBER and related centers.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
21 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing year five of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to assist with CMC readiness for products regulated by both the Center for Biologics Eval
The full text is at the source

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