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USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
May 11, 20242 min read
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USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
Sharan Murugan
Jan 4, 20231 min read
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