The Food and Drug Administration today released draft guidance for assessing risk evaluation and mitigation strategies. FDA may require a REMS before approving certain drugs, including biologics, to help ensure its benefits outweigh its risks. FDA Commissioner Scott Gottlieb, M.D., said the guidance provides a framework for companies to develop an assessment plan when they develop a REMS program to improve the quality of the information used to assess the program’s effectiveness and provide post-market evidence that the REMS is meeting its risk mitigation goals. “We need to make sure that the REMS are achieving their public health goals, and that we’re designing and implementing these approaches in ways that minimize burdens to patients and providers,” he said.

Related News Articles

Headline
The AHA Quest for Quality Prize honors hospitals and health systems committed to leadership and innovation in improving quality and advancing health. Learn how…
Headline
A JAMA study published Aug. 20 found that nearly 63% of all U.S. drug production facilities from 2019 through 2024 were in counties where a weather disaster…
Blog
Read about the 2025 Quest for Quality Prize winner and finalist — and apply for the 2026 awardEach day, health care professionals across the U.S. leverage…
Perspective
Public
Hospitals and health systems across the country vary in size, as well as the types of services and specialties they offer. They also offer many different…
Headline
The AHA Aug. 7 launched a new webpage, Reducing Disparities in Health Outcomes, featuring new and familiar resources for members and their communities. As part…
Headline
Nell Buhlman, chief administrative officer and head of strategy at Press Ganey, and Chris DeRienzo, M.D., AHA chief physician executive, explore the data-…