The Food and Drug Administration seeks stakeholder input on how it might use Risk Evaluation and Mitigation Strategies to facilitate appropriate prescribing of opioid pain relievers. For example, the agency’s Opioid Policy Steering Committee is considering using REMS to require sponsors to ensure that opioid analgesic prescriptions exceeding a certain amount document medical necessity and/or leverage a nationwide prescription history database to prevent misuse or abuse, the FDA notice states. The agency will hold a Jan. 30 public hearing on the issue, with comments accepted through March 16.

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The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug…
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Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of…
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A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study…
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The Food and Drug Administration Aug. 5 approved the first mRNA-based flu vaccine, called mFlusiva. The vaccine is manufactured by Moderna and was approved for…
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The Senate soon is expected to join House colleagues in returning home to their states and districts. These traditional August state and district work periods…
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The AHA will host a webinar Aug. 19 at 1 p.m. ET on how to implement behavioral threat assessment and management programs to address workforce violence risks,…