Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
EconoTimes

FDA Fast-Track Drug Reviews Delayed Over Safety and Efficacy Concerns

The U.S. Food and Drug Administration has delayed reviews of several drugs selected for the Trump administrations new ...

FDA Shows Caution, Delays Trump-Backed Fast-Track Drugs Over Risks

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported ...
Devdiscourse

FDA Delays Highlight Safety Concerns in Fast-Track Drug Program

The FDA postponed reviews for two drugs in the Trump administration's fast-track program due to safety and efficacy concerns.
Devdiscourse

FDA Prioritization Program Stalls: Safety Concerns Cause Delays

The FDA has delayed reviews of drugs under its fast-track program due to safety and efficacy concerns, including trial data issues and adverse events. This includes Disc Medicine's rare blood disorder ...
Benzinga.com

FDA Unveils First Experimental Drugs Under Fast-Track Voucher Plan To Cut Drug Review Times

The Food and Drug Administration announced on Thursday the first round of experimental drugs to be included in a priority voucher program. This FDA initiative is designed to expedite drug review ...
Yahoo

US FDA approves first drug under new fast-track review program

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo Dec 9 (Reuters) - The U.S.
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Atossa Therapeutics stock jumps after FDA grants rare pediatric status to DMD drug — retail bets on phase 3 fast-track

・The FDA designation expands Atossa’s investigational therapy into rare pediatric neuromuscular disease. ・The program could become eligible for a Priority Review Voucher upon future approval.