News

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.
MIT Technology Review4h
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 ...
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 ...
Meet the vaccines skeptics that are now part of RFK Jr.’s vaccine approval committee
Health and Human Services Secretary Robert F. Kennedy, Jr., has announced new members of the Centers for Disease Control and ...
Clinical Trials Arena1d
Policy changes and digital strategies guide oncology research
At the CTO West Coast conference, experts discussed the future of oncology clinical trials and key themes surrounding them.
FDA wants to use AI to speed up drug approval process
The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump ...
Fierce Biotech1d
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 ...
Becker's Hospital Review1d
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 ...
BioSpace1d
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 ...
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 ...
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, ...
Precision Medicine Online2d
In New FDA Priorities, Is There Room for Precision Medicines?
In JAMA, the FDA's Makary and Prasad said they will focus on modernizing review processes and lowering drug costs but don't outright mention precision medicine.