FDA launches pilot program to speed up early drug trials

The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
STAT

FDA to launch pilot program to speed up early-stage clinical trials

WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
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FDA 'Priority Voucher' Program Comes Under Congressional Scrutiny

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
Truckinginfo

FDA Program Will Put More RFID Tags in the Freight Stream

The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Mark your calendar: June 30, 2026 (10:00 a.m. PDT). A 37.5% ownership interest in ...
Medical Xpress

FDA unveils drugs to receive expedited review in support of 'national priorities'

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
BioSpace

Denali sells FDA voucher for $195M to support neurodegenerative pipeline

Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...
MarketWatch

Regenxbio Shares Plunge on FDA Pausing Two Drug Development Programs

Shares of Regenxbio plunged after the Food and Drug Administration placed clinical holds on two drug development programs after a five-year-old participant in one study developed an intraventricular ...
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Neuren Pharmaceuticals shares FDA meeting feedback on NNZ-2591 clinical programs

Yesterday afternoon, Neuren Pharmaceuticals Ltd (ASX: NEU) shared feedback from recent US FDA meetings on its NNZ-2591 clinical programs. Neuren said it received constructive guidance for its ...