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Home » FDA Posts PDUFA VII Meeting Minutes Centered on Sentinel, REMS Assessments
FDA Posts PDUFA VII Meeting Minutes Centered on Sentinel, REMS Assessments
The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments.