federalnewsnetwork.com18h
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
What to Expect from Robert F. Kennedy Jr.’s Confirmation Hearings
If confirmed by the Senate, Kennedy would head the Department of Health and Human Services (HHS), which oversees many of the ...
Popular Science8d
FDA approves first-of-its-kind nasal spray for severe depression
The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...
FiercePharma13d
Government watchdog recommends tweaks to FDA accelerated approval program
A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...
Forbes6d
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Patented genetics from Charlotte’s Web were used in the process. There are very rare instances when cannabis-based drug candidates have achieved FDA approval, with only one containing cannabis ...