Alexion’s risk management program could benefit from easing current requirement for MedGuide distribution with every infusion and streamlining surveys of prescribers’ knowledge about meningococcal risks.
The Risk Evaluation and Mitigation Strategy for Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) should be modified to streamline the program’s educational materials and assessment process, a panel of FDA’s external advisors said Nov. 18.
Although no formal vote was taken, a majority of the agency’s Drug Safety and Risk Management Advisory Committee favored revising...
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.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
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.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
