News

FDA commissioner predicts ‘record’ drug approvals this year
FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...
FDA vaccine chief leaving agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration's top vaccine regulator after a brief tenure.
US FDA's top vaccine official Vinay Prasad leaves agency after 3 months
The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...
News-Medical.Net3h
FDA Breakthrough Device designation granted for AI-based mammogram analysis tool
A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized ...
360Dx4h
Becton Dickinson Veritor COVID Test Receives FDA 510(k) Clearance
The 15-minute digital lateral flow immunoassay originally obtained Emergency Use Authorization from the US FDA in 2020.
Chemistry World5h
Sarepta gene therapy deaths highlight tragic rare disease dilemma
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course | Stay Ahead with Insights into IND, NDA, ANDA, and 505(b)(2) Submissions (ONLINE EVENT: October ...
Join our comprehensive FDA regulatory course to navigate submissions for INDs, NDAs, ANDAs, and 505(b)(2). Gain insights into FDA processes, recent changes, and strategic needs, featuring expert-led ...
Food Safety News14h
The FDA recommends scheduling kratom’s 7-OH under the Controlled Substances Act
Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action ...