HHS’ Adverse Drug Event Action Plan Calls For New Treatment Guidelines
This article was originally published in The Pink Sheet Daily
Draft recommends research and initiatives that could lead to changes in drug prescribing practices to reduce the likelihood of adverse drug events – and may even include more prescribing if adverse drug events can be mitigated.
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HHS is declaring a priority of reducing the burden of adverse events associated with three large classes of drugs: opioids, antidiabetics, and anticoagulants. And, at least in its draft action plan, FDA is not the central actor.
HHS expects device and drug manufacturers, as well as other industry stakeholders, to provide ongoing feedback to aid the agency's development of its official National Quality Strategy for health care, the agency said in a March 21 report to Congress.
As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals
J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.