US FDA and European Medicines Agency may expand sharing beyond manufacturing inspections to clinical trials and generic drug applications.
US FDA and the European Medicines Agency may expand their collaboration to include such topics as generic drug reviews and good clinical practices.
Officials from the two regulatory bodies participated in a panel devoted to answering industry questions at the Drug Information Association's...
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.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
