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Goodbye NSURE, Hello ACNU! FDA Issues Long-Awaited Proposed Rule to Bring OTC Drugs with a Little Something Extra to Market

FDA Law Blog

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug. This brings us back to the ANDAs.

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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. It’s not surprising that the number of repeat calls for falls is alarmingly high. Alex: I think this is a first.

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Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Is 4% meaningful? I think it’s you, Bob.

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Should We Shift from Advance Care Planning to Serious Illness Communication?

GeriPal

And I’m worried about all of us as healthcare workers, but particularly… And when I say particularly those in the hospital, because they are just tired. And I’m worried about all of us as healthcare workers, but particularly… And when I say particularly those in the hospital, because they are just tired.

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Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.