FDA Seeks Applicants for CDRP Pilot Program

The FDA is inviting applications from sponsors who want to take part in the agency’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program aimed at providing patients earlier access to drugs where there is anticipated clinical benefit.

The pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches.

The agency outlined the eligibility criteria and process for submitting a request to participate in the pilot in a Federal Register notice. Those who are interested in the program are invited to submit requests starting April 1, 2023.

Read the agency’s notice here: bit.ly/3NwMHVn.