FDA Opens PreCheck Pilot Applications Ahead of March 1 Deadline
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The U.S. Food and Drug Administration (FDA) has initiated the PreCheck Pilot Program, accepting applications from February 1 to March 1, 2026. This program is designed to streamline the assessment process for new pharmaceutical manufacturing facilities in the United States, enhancing regulatory predictability and supporting the construction of domestic sites. Facilities will be selected based on alignment with national priorities, including the types of products to be manufactured and their development timelines. The FDA plans to select an initial cohort by June 30, 2026, with pre-operational engagements commencing on July 1.
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Key Entities
- • FDA - U.S. Food and Drug Administration, the regulatory body overseeing the program.
- • Pharmaceutical Manufacturers - Companies involved in producing medications, eligible to apply for the program.
Bias Distribution
Source & Verification
Source: Healthmanagement
Status: Confirmed
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