FDA initiates a CMC development and preparation pilot program to accelerate the development of CMC for investigational new drug application products

US FDA on October 31 A notice was issued in the Federal Register announcing the launch of the Chemistry, Manufacturing and Control (CMC) Development and Preparation Pilot (CDRP) program to facilitate the acceleration of products under investigational new drug (IND) applications if necessary, based on the expected clinical benefit of the product being obtained earlier by patients CMC development
.

The FDA said the pilot program was implemented to help prepare some regulated products for CMC to accelerate clinical development timelines
.
The pilot will increase the FDA Communicate with sponsors and explore the use
of science- and risk-based regulatory approaches.

The FDA notes that those products that accelerate development in drugs and biologics regulated by the Center for Biologics (CBER) and the Center for Pharmaceuticals (CDER) may be accelerating CMC Development activities face challenges
in aligning with accelerated clinical timelines.
Successfully accelerating CMC readiness may require working with the FDA during product development Streamline CMC development activities
by engaging in additional interaction and, where applicable, guaranteeing the use of science- and risk-based regulatory approaches.
This pilot program is based on the FDA Initiated
under the Prescription Drug User Paid Reauthorization Act (PDUFA VII) commitment.

Beginning in fiscal year 2023, FDA will conduct CDRPs on selected products to facilitate CMC under the IND Development
.
These selected products include or Breakthrough Therapy (BT), Fast Track (FT) and Advanced Regenerative Medicine Therapies (RMAT) designation
.
For sponsors participating in the pilot, FDA Product-specific CMC recommendations will be provided during product development, including two additional CMC-focused Type B sessions, and a limited number of additional based on readiness and identified CMC milestones CMC focused discussion
.

The FDA plans to accept requests to participate in the CDRP program and select up to nine proposals beginning April 1, 2023, of which approximately two-thirds are CBER-regulated products and one-third are CDER-regulated products
.
Sponsors interested in participating in the pilot should submit a request
to IND to participate in the pilot as an addendum.
The cover letter should state "Request to participate in CMC development and preparation pilot"
.

To promote innovation and understanding in the field, FDA may (e.
g.
, at a public workshop) disclose lessons learned from pilots as case studies, including those products in pilot studies that have not yet received an FDA Circumstances of
approval.
In the future, FDA plans to hold a public workshop and publish a strategy document that focuses on CMC based on lessons learned from CDRP aspects of accelerated development
.
Participation in the pilot project is voluntary and at the discretion of
the sponsor.

Original link in English: https://endpts.
com/fda-to-kick-off-cmc-readiness-pilot-program-next-april/