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FDA launches PreCheck pilot to speed review of new U.S. drug manufacturing facilities

Market News
29 Jun 2026
CNBC
View Source
Bullish
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The FDA has selected seven companies, including Eli Lilly and Regeneron, for its new PreCheck pilot program aimed at accelerating regulatory review of new pharmaceutical manufacturing facilities in the U.S. This program allows the FDA to review facilities while they are still under construction, potentially saving up to 14 months in approval time. The initiative supports the Trump administration's push for increased domestic drug production, focusing on complex biologic and genetic medicines. Participating companies include those making drugs to fill supply gaps or address unmet medical needs, with facilities in states like Indiana, New York, and North Carolina.

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