FDA Selects 7 Drugmakers for PreCheck Pilot as 80+ Applications Filed

The U.S. Food and Drug Administration (FDA) selected seven pharmaceutical companies for its PreCheck pilot program, according to official announcement. Eli Lilly, Regeneron Pharmaceuticals, Fujifilm Biotechnologies, Amneal Pharmaceutical, Cellares, Kriya Therapeutics, and Kyowa Kirin were chosen to participate in the initiative, which aims to streamline regulatory pathways for new drug manufacturing facilities through early FDA engagement. The program received more than 80 applications between February 1 and March 1, 2026. Participants will collaborate with FDA through a two-stage process consisting of facility preparation and application submission phases.
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