# Federal Register #FDA-2022-N-2396

FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program Announcement

**Buyer:** Food and Drug Administration
**Posted:** September 21, 2026
**Identifier:** FDA-2022-N-2396
**NAICS:** 541715

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is announcing year five of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program.
- Government Buyer:
  - Food and Drug Administration (FDA), Department of Health and Human Services
- Program Overview:
  - Supports expedited CMC development for investigational new drug applications (INDs) with accelerated clinical timelines
  - Open to products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)
- OEMs and Vendors:
  - No specific OEMs or vendors named; program is open to eligible IND sponsors
- Products/Services Requested:
  - Participation in the CMC Development and Readiness Pilot Program
  - Includes increased FDA-sponsor communication, additional CMC-focused meetings, and expanded IND quality assessment teams
- Unique or Notable Requirements:
  - Eligibility requires active commercial INDs in eCTD format
  - Must have expedited clinical development designations (e.g., Breakthrough Therapy, Fast Track)
  - Commitment to a CMC development plan aligned with accelerated timelines
  - Up to nine proposals selected annually, balanced between CBER and CDER products
  - Submission of a CMC development plan and participation in dedicated meetings
  - Addressing anticipated CMC challenges for earlier patient access
- No specific products, part numbers, or purchase quantities listed; this is a program announcement rather than a product solicitation

### Description

The Food and Drug Administration (FDA) announces year five of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. This pilot facilitates expedited CMC development of products under investigational new drug applications (INDs) with accelerated clinical development timelines, aiming to enable earlier patient access. The program supports products regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) through increased communication and science- and risk-based regulatory approaches. FDA will accept requests to participate starting October 1, 2026, selecting up to nine proposals annually. The pilot includes additional CMC-focused meetings and expanded IND quality assessment teams to support CMC readiness.

[View original listing](https://www.federalregister.gov/documents/2026/09/21/2026-19277/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement)