# 2025-15799: FDA Shares Drug-Making Lessons: Workshop Seeks Feedback

2025-15799, Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-08-19 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-15799
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-15799
- Title: Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 40371
- Published: 2025-08-19
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Shares Drug-Making Lessons: Workshop Seeks Feedback

## Summary

The FDA is hosting a virtual workshop to share what they’ve learned from a special pilot program that helps speed up the chemistry and manufacturing steps for new drugs. This affects drug makers and patients waiting for faster access to promising treatments. The workshop will gather feedback to improve future policies, aiming to make drug development quicker and smoother without extra costs or delays.

## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual-only public workshop entitled "Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program." This workshop fulfills a commitment in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII) to hold a public meeting to discuss best practices and lessons learned from this pilot program. Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will feature sponsors and FDA experience under this pilot program and will solicit input on future directions for FDA policy and programs to facilitate expedited CMC development of products under an investigational new drug application (IND), where indicated based upon the anticipated clinical benefits.

## Effects PRIA read

- FDA Workshop on Speeding Drug Manufacturing: benefit, low. The FDA is hosting a virtual public workshop called the CMC Development and Readiness Pilot (CDRP) Lessons Learned meeting to share sponsor and Agency experience under the pilot and to collect feedback. The workshop will solicit input on future FDA policy and programs to help facilitate expedited c…

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## Sources
- [2025-15799 on federalregister.gov](https://www.federalregister.gov/documents/2025/08/19/2025-15799/lessons-learned-from-the-chemistry-manufacturing-and-controls-development-and-readiness-pilot)
- [2025-15799 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-08-19/pdf/2025-15799.pdf)

## Related
- [Previous: 2025-15798, National Institute of Environmental Health Sciences; Notice of Meeting](https://policyrisk.com/federal-register/2025-15798)
- [Next: 2025-15800, Center for Scientific Review; Notice of Closed Meetings](https://policyrisk.com/federal-register/2025-15800)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-15799 (as of 2026-06-08).