<p>The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United States.</p>
<p>The program is designed to encourage companies to invest in domestic drug production and research by offering faster approvals for products made with U.S.-sourced ingredients and tested within the country.</p>
<p>Earlier this week, the FDA held a public meeting to discuss its broader efforts to support U.S. pharmaceutical manufacturing, including the PreCheck program, which aims to help set up high-priority drug facilities more quickly.</p>
<p>The FDA said these steps will help strengthen the U.S. drug supply chain and bring high-quality, U.S.-made generic drugs to market more quickly.</p>
<p>More than half of the pharmaceuticals distributed in the United States are made overseas, according to the health regulator.</p>
<p>As of 2025, only 9% of companies that produce the key ingredients in drugs &#8211; known as active pharmaceutical ingredients &#8211; are based in the U.S., compared to 22% in China and 44% in India, the FDA said.</p>
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<p>&#8220;Over-reliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,&#8221; said George Tidmarsh, Director of FDA&#8217;s Center for Drug Evaluation and Research.</p>
<p>&#8220;It also slows down reviews and costs taxpayers more money,&#8221; he added.</p>
<p>The FDA also noted many important studies used to approve drugs &#8211; including tests to show that generic drugs work the same as brand-name ones &#8211; are now often done outside the U.S., which is weakening the country&#8217;s ability to lead in drug research and development.</p>
<p>(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)</p>

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FDA Launches Pilot Program To Fast-Track Review Of Generic Drugs Made In U.S.