George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...
The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...
FDA grants 1st approval under priority voucher program to Augmentin XR, expediting review and supporting U.S. antibiotic supply chain resilience.
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON (AP) — The Food and ...
The U.S. House of Representatives has given a unanimous thumbs up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December ...
The Food and Drug Administration has launched a new transparency policy for the reporting of foodborne illness outbreak investigations. As part of the initiative the public, industry stakeholders and ...
FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...
Saol Therapeutics received a complete response letter for its pyruvate dehydrogenase complex deficiency treatment a week ...
The U.S. Food and Drug Administration said on Tuesday it had approved the first gene therapy for a rare and life-threatening ...
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