Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...
This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...
FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...
The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for psychedelic drugs, a move that directly clears a path for psilocybin, the active ...
According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
After public backlash, the FDA will review a new mRNA flu vaccine. That's good news, but its original rejection and other arbitrary decisions undermine U.S. leadership in biopharmaceutical innovation.