The Food and Drug Administration today released draft guidance for assessing risk evaluation and mitigation strategies.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.
The Department of Health and Human Services has updated its guidance to help communities prepare for and respond to chemical incidents requiring mass…
The Centers for Medicare & Medicaid Services has extended the deadline for submitting third-quarter data to the Post-Acute Care Quality Reporting Program.
The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
Hospitals and clinicians are seeing fewer flu patients this season than in other recent years, the Centers for Disease Control and Prevention reports.
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Share how your organization is working to improve health equity – apply for the AHA Equity of Care Award Applications for the 2019 AHA Equity of Care Award are due by Feb. 19
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Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a…