By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
The PreCheck programme, first unveiled in June 2025, aims to speed up drug facility construction.
On February 1, FDA announced a new pilot program designed to promote the construction of domestic manufacturing sites, along ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.
FDA debuts domestic pharma supply chain plan to streamline facility assessments and accelerate U.S. pharmaceutical manufacturing readiness.
WASHINGTON, D.C. — The U.S. Food and Drug Administration is rolling out a sweeping set of initiatives aimed at reshaping the nation’s drug and food systems, launching a new pilot ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US and make the domestic sector more resilient and competitive. This program ...
With the FDA tightening its guidance around the production of nonbacterial beta-lactam drugs, Swedish CDMO Recipharm is ...
The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities.
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