Home » Stakeholders Take Issue With FDA REMS Draft Guidance
Stakeholders Take Issue With FDA REMS Draft Guidance
The FDA’s draft guidance on
risk evaluation and mitigation strategies (REMS) for drugs and biologics does not adequately explain when a REMS is required and suggests an implementation
timeline that would be difficult for generic-drug makers to meet, industry says in comments on the draft. While the guidance summarizes the statutory requirements
under which a REMS may be required, it fails to describe how the FDA will determine when a REMS should be required or amended, PhRMA says in its comment — one
of 31 submitted by the Dec. 30 deadline.
Drug Industry Daily
Drug Industry Daily
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