November 19, 2025

The U.S. Food and Drug Administration (FDA) has released new updates regarding the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program, aimed at accelerating CMC readiness for products under expedited clinical development pathways. Beginning October 1, 2025, FDA will start accepting requests to participate in Year Four of the CDRP Program, continuing efforts to support rapid development and earlier patient access to critical therapies.

Understanding the Purpose of CDRP

The CDRP Program was first launched in October 2022 to support CBER- and CDER-regulated products with accelerated development timelines. The program promotes early and structured communication between sponsors and FDA to help streamline CMC planning and readiness.

Core Objectives of the CDRP Program

  • Facilitate expedited CMC development aligned with accelerated clinical timelines.
  • Strengthen communication channels between FDA and sponsors.
  • Enable earlier patient access to innovative therapies.
  • Support CMC strategy planning through structured meeting opportunities.

This is particularly beneficial for cell and gene therapies, biologics, advanced therapeutics, and innovative drug modalities where CMC readiness often lags clinical progress.

CDRP Program Highlights and What’s New

Announcement Date

Update Description

August 28, 2025

FDA will begin accepting participation requests for Year Four on October 1, 2025.

August 12, 2025

FDA announced a virtual public workshop titled “Lessons Learned from the CDRP Program.”

Workshop Date

September 10, 2025, 1:00 PM – 5:00 PM (Eastern Time)

The public workshop aims to discuss progress, sponsor experiences, best practices, and opportunities to further align regulatory expectations with development strategies.

How the Program Works

Sponsors accepted into the CDRP Program will receive:

  • Two dedicated Type B meetings with FDA CMC reviewers.
  • Opportunities for follow-up clarification discussions.
  • Support in aligning CMC activities with accelerated development plans.
  • Guidance to ensure CMC data readiness for marketing application submission.

This enhanced collaboration helps reduce development delays and strengthens regulatory predictability.

Eligibility and Application Process

Sponsors seeking to participate must:

  1. Submit a request as an amendment to their IND.
  2. Include the statement:
     “Request to participate in the CMC Development and Readiness Pilot.”
  3. Review eligibility criteria in the Federal Register Notice.

Program Capacity:

  • Up to nine proposals per year will be selected.
  • ~2/3 for CBER-regulated products and ~1/3 for CDER-regulated products.
  • Program continues through FY 2027 (PDUFA VII timeframe).

Why This Matters to Drug Developers

The CMC stage is often one of the most challenging components when timelines are compressed. Delays in process validation, comparability plans, analytical development, or manufacturing scale-up can slow regulatory submissions.

The CDRP Program helps reduce this risk by:

  • Encouraging early strategic planning.
  • Ensuring CMC milestones align with clinical milestones.
  • Reducing regulatory uncertainty during high-speed development.

Conclusion

The FDA’s continued support of the CDRP Program underscores the importance of CMC readiness in accelerating safe and timely access to innovative therapies.

At Maven Regulatory Solutions, we assist sponsors in:

  • CMC regulatory strategy development
  • IND and BLA/NDA submission planning
  • CMC data gap assessment
  • Regulatory meeting preparation and agency communication

A proactive approach to CMC regulatory planning is not just beneficial—it is essential for success in accelerated development pathways.