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 ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding up construction and review of ...
FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
A new drug application (NDA) and a biologics license application (BLA) have been resubmitted and accepted by the FDA for ...
Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...
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.
The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of ...
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