FDA launches FDA PreCheck program

Aug. 12, 2025

The U.S. Food and Drug Administration (FDA) has launched a new program to promote U.S. drug manufacturing. The initiative, FDA PreCheck, is described in a release.

One of the goals of FDA PreCheck is to reduce the United States’ dependence on foreign drug manufacturers. It will increase “regulatory predictability” and aid “the construction of manufacturing sites in the United States.”

PreCheck will focus on two steps to promote U.S. drug manufacturing: communication and simplifying the application process. The FDA is holding a virtual and in-person meeting on September 30 to discuss FDA PreCheck.

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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