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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.
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Reuters broke the news in United Kingdom on Thursday, August 7, 2025.
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