US FDA Asks Manufacturers To Fix Disruption In Isotretinoin REMS
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.
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REMS modification implemented for the duration of the pandemic will become permanent, the agency determines in response to lawsuit. FDA adds a requirement that pharmacies dispensing the drug be certified.
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.
US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.