Tocilizumab Shortage Prompts US FDA To Loosen CAR-T REMS Requirements
CAR-T cell immunotherapies can be administered when only one dose of Roche's Actemra is available on-site for each patient, rather than two doses required under REMS for the immunotherapies. The change is one of the few pandemic-related REMS revisions that has been made public.
You may also be interested in...
US FDA is once again considering changes to the Risk Evaluation and Mitigation Strategy for the acne medication, a year after modifications to the program caused disruptions in patient access.
The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.
While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.