Home » Expert: FDA Needs Predictability in REMS Development
Expert: FDA Needs Predictability in REMS Development
Drugmakers need guidance from the FDA to clarify when the agency would require companies to develop risk evaluation and mitigation strategies (REMS). Although the agency has used its new postmarketing surveillance powers judiciously, drugmakers need help understanding the REMS development process, former FDA Associate Commissioner for External Relations Peter Pitts said.
Washington Drug Letter
Washington Drug Letter
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