The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
The US Food and Drug Administration now has employees working at the Centers for Medicare and Medicaid Services as part of the increased collaboration spurred by the 2022 Inflation Reduction Act.
FDA Commissioner Robert Califf indicated his employees are helping CMS implement the IRA, which among its many provisions includes the...
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
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.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
