US FDA moves to boost domestic drug manufacturing after Trump push
UNITED STATES, AUG 7 – FDA PreCheck aims to reduce regulatory delays and increase domestic drug manufacturing, addressing reliance on foreign sources responsible for nearly 90% of active pharmaceutical ingredients.
- On Aug. 7, 2025, the Food and Drug Administration launched the FDA PreCheck program to streamline US drug manufacturing approval processes, including a two-phase approach.
- Supply chain data show more than half of U.S. medicines are made overseas, and only 11% of active pharmaceutical ingredients are produced domestically, prompting FDA actions.
- Following that, the Application Submission Phase aims to streamline the Chemistry, Manufacturing, and Controls section through pre-application meetings and early feedback, as the Food and Drug Administration outlines.
- Stakeholders will gather at a session titled `Onshoring Manufacturing of Drugs and Biological Products` to discuss domestic drug supply challenges, following the FDA's Aug. 7, 2025, announcement.
- Still, building new drug factories can take years, so the billions for 2025 will have minimal impact as the FDA aims to boost domestic pharmaceutical supply.
22 Articles
22 Articles
FDA to Boost Domestic Pharmaceutical Production
The Food and Drug Administration (FDA) unveiled a new plan to boost the nation’s domestic pharmaceutical supply. “Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug s…
FDA Fast-Tracks Domestic Drug Manufacturing with PreCheck
The FDA introduces ‘PreCheck,’ a program aiming to expedite the construction and review of drug manufacturing plants in the U.S. This initiative seeks to boost domestic drug supply, aligning with governmental goals to reduce dependency on foreign sources. Major pharmaceutical companies support this push with significant investments.
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