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FDA launches pilot program to fast-track review of domestically made generic drugs

Reuters
By Reuters
1 Min Read Oct. 3, 2025 | 3 months Ago
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The U.S. Food and Drug Administration 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, the regulator said on Friday.

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.

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.

The FDA said these steps will help strengthen the U.S. drug supply chain and make high-quality generic medicines more available to American consumers.

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