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Investing.com -- The U.S. Food and Drug Administration launched a new program called FDA PreCheck on Thursday to strengthen domestic pharmaceutical manufacturing and reduce reliance on foreign suppliers.
Currently, more than half of pharmaceuticals distributed in the U.S. are manufactured overseas, with only 11% of active pharmaceutical ingredient (API) manufacturers for FDA-approved products based in the United States.
"Our gradual overreliance on foreign drug manufacturing has created national security risks," said FDA Commissioner Marty Makary, M.D., M.P.H. "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 supply."
The program was developed in response to Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," which directs the FDA to streamline review processes and eliminate unnecessary regulatory requirements.
FDA PreCheck introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities. The first phase, called Facility Readiness, provides manufacturers with more frequent FDA communication during facility design, construction, and pre-production stages. Companies are encouraged to submit comprehensive facility information through a Type V Drug Master File.
The second phase, Application Submission, focuses on streamlining the Chemistry, Manufacturing, and Controls section of applications through pre-application meetings and early feedback.
The FDA will host a public meeting titled "Onshoring Manufacturing of Drugs and Biological Products" on September 30, 2025, at the FDA White Oak Campus in Silver Spring, Maryland. Virtual participation will be available. The meeting will present the FDA PreCheck draft framework and include stakeholder discussions on overcoming onshoring challenges.
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