Stakeholders Take Issue With FDA REMS Draft Guidance

The FDA’s draft guidance on risk evaluation and mitigation strategies (REMS) for drugs and biologics does not adequately explain when a REMS is required and suggests an implementation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