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fda press·Jun 29·1 min read
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FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing

Jun 29, 2026·read at fda press ↗RegulatoryPositive

The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience.

The program, launched on Feb 1, 2026, follows an executive order from May 2025 and a public meeting on domestic manufacturing challenges. It seeks to give companies earlier regulatory engagement and a clearer pathway when building new manufacturing facilities for the U.S. market.

By encouraging early FDA interaction, the pilot hopes to increase domestic production of critical medicines, create high-quality jobs, and reduce reliance on overseas sources.

The FDA received more than 80 requests for the pilot between Feb 1 and March 1, 2026, indicating strong industry interest in the new framework.

source

This writeup was produced by pharmadog from original reporting by fda press.

Original headline: “FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing”

read at fda press ↗
848 words · retrieved Jul 29
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companies & drugs in this story

companies
AMNEAL2ELI LILLY CO2LILLY2CYCLEEli Lilly and CoKYOWA KIRINOVERSEASREGENERON PHARMACEUTICALSREGENERON PHARMACEUTICALS, INC.Ultragenyx Pharmaceutical Inc.
topics
Gene Therapy (AAV)3ApprovalHematologyOncologyPainPulmonologyRare DiseaseSmall MoleculeVaccines

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