The Food and Drug Administration (FDA) is announcing the year two opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to facilitate the expedited CMC development of products under an investigational new drug application (IND), where warranted, based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.
Starting October 2, 2023, FDA will accept requests to participate in the CDRP program. See the “Participation” section of this document for eligibility criteria, instructions on how to submit a request to participate, and selection criteria and process.
For Further Information Contact
Tanya Clayton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20993–0002, 301–796–0871; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7256, Silver Spring, MD 20993–0002, 240–402–5683.
For general questions about the CDRP Program for CBER: [email protected].
For general questions about the CDRP Program for CDER: [email protected].
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