On August 7, 2025, the Food and Drug Administration announced a voluntary "FDA Pre-Check" program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based regulatory pathway. While many details remain to be finalized, the framework signals FDA's commitment to supply-chain resilience, advanced manufacturing, and mature quality-management systems. The program was developed in response to Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines."
The Pre-Check program proposes a two-phase approach to facilitate new U.S. drug manufacturing facilities—(1) facility readiness phase, and (2) application submission phase. FDA is hosting a public meeting titled "Onshoring Manufacturing of Drugs and Biological Products" on September 30, 2025, from 9:00 AM to 4:00 PM, which can be attended in-person or virtually. The meeting will present the draft Pre-Check framework and seek specific input on a list of four specific questions. Comments can also be submitted through the Federal eRulemaking Portal (Reference FDA-2025-N-2489-0001).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
