FDA Kicks Off Year Five Drug Development Speed Pilot
Published Date: 9/21/2026
Notice
Summary
The FDA is launching year five of its Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to help speed up the development of important new drugs and biologics. This program boosts communication between the FDA and drug makers to get safe, effective products ready faster, especially for serious diseases with urgent needs. Starting October 1, 2026, eligible companies can apply to join and benefit from this faster, smarter review process.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
CDRP Year Five Opens Oct 1, 2026
Starting October 1, 2026, companies can submit requests to join year five of the FDA's CMC Development and Readiness Pilot. FDA will select no more than nine proposals per fiscal year (about two-thirds CBER-regulated and one-third CDER-regulated); selected sponsors receive increased communication with FDA, two additional CMC-focused Type B meetings, an expanded IND quality assessment team, and remain enrolled until their marketing application is filed. FDA intends to issue a Proceed to Disclosure Agreement letter or deny letter within 90 days of receipt.
Eligibility: INDs, eCTD, and Designations
To be considered, sponsors must have an active commercial IND (submitted in or converted to eCTD format unless waived) and submit a Request To Participate as an amendment to the IND including a CMC development plan and timeline. CBER-specific entries must be CBER-regulated INDs intended for licensure under section 351(a) and have Breakthrough Therapy (BT) or RMAT designation; CDER-specific entries must be CDER-regulated INDs intended for approval under section 505(b) or licensure under 351(a) and have an expedited clinical timeframe (for example, BT or Fast Track) as determined by FDA.
Aim: Speed Earlier Patient Access
The pilot is intended to facilitate expedited CMC development so safe, effective drugs and biologics in accelerated clinical programs can reach patients earlier, especially for serious diseases with unmet medical need. FDA will administer the pilot through the PDUFA VII period and accept requests beginning October 1, 2026, with the program continued and announced each fiscal year through the end of FY 2027.
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