News

Commentary: Keep FDA moving forward, not backward
The FDA’s accelerated approval pathway plays a vital role, and scrapping it or reversing course on already-approved therapies ...
The FDA Wants AI To Speed Up Health Care Decisions — Here's Why Experts Are Concerned
A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.
BioSpace2d
Makary, Prasad Lay Out Mission for FDA in Journal Kennedy Called ‘Corrupt’
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...
Medpage Today on MSN3d
FDA Officials Lay Out Vision for Agency
The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...
pharmaphorum2d
Makary, Prasad set out their vision for the FDA
Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...
Fierce Biotech2d
FDA aims for 'rapid or instant' drug reviews, with AI tool initially assessing applications
The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...
Bloomberg L.P.1mon
FDA Appointee Is a Drug Critic With a Lot to Prove
The controversial appointment of oncologist Vinay Prasad — an outspoken ... Now, as the director of the Center for Biologics Evaluation and Research, which oversees vaccines, gene therapies ...
MIT Technology Review22h
Here’s what food and drug regulation might look like under the Trump administration
Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...
Becker's Hospital Review2d
FDA employs AI in effort to accelerate drug approvals
The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA ...
BioSpace2d
As Gene Therapy Endures ‘Cold Winter,’ FDA Leaders Promise Support
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...
STAT4d
Pharmalittle: We’re reading about FDA and gene therapies, a kidney disease showdown, and more
Fears about the FDA imposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...
Just The News3d
'Rubber stamp' vaccine advisory board fired by RFK Jr. for conflicts of interest has revealing past
CDC's Advisory Committee on Immunization Practices once recommended vaccine after official admitted it had no data on ...