CDER to Standardize REMS Under PDUFA V, Issue Guidance
CDER plans to standardize REMS development to make the safety tools more effective and less burdensome for drugmakers.
A REMS integration steering committee (RISC) of senior CDER leadership (with CBER involvement) will lead the way in the standardization, as well as developing REMS-related guidance mandated under PDUFA V.
The fifth authorization of PDUFA moves REMS discussions earlier in the review process for sponsors of new molecular entity NDAs and original BLAs. With REMS discussions commencing as early as pre-NDA meetings, the agency will need a more predictable system for requiring REMS and deciding what tools a REMS should involve, CDER Deputy Director for Safety Mary Ross Southworth said last month.
With the Food and Drug Administration Amendments Act of 2007 barely in the rear view mirror and PDUFA V to deal with, drug safety, REMS and pharmacovigilance in the U.S. are undergoing significant changes.
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