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Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

FDA Law Blog

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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While the Orphan Battles Wages, Jazz Takes a Loss

FDA Law Blog

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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Nurse Practitioners Critical in Treating Older Adults as Ranks of Geriatricians Shrink

Physician's Weekly

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine. “Hello. How are you feeling?”

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DEA Proposes Additions to Longstanding Precursor Chemical Special Surveillance List

FDA Law Blog

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 39,479, (June 16, 2023).

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An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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