US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.
The US Food and Drug Administration’s neurology drugs program received a funding boost in fiscal year 2023 to stay abreast of the evolving landscape, despite the controversy over its approval of Alzheimer’s treatments.
The omnibus appropriations bill enacted in December included an additional $2m that lawmakers said was intended for the agency...
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
