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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

As an editor, movement media and narrative strategist, and storyteller, Harrison uses their extensive history as a community organizer—which began in 2014 during their first year at Morehouse College—to frame their political thought and cultural criticism. Physical Fitness.” On one hand, we must not moralize food choices.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing.

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

Elders Climate Action, and let me just tell you a little bit about who we are, was created in 2014 as the project of a 501(c)(3), Elders Action Network. So it is an enormous mental, physical health benefit because we feel we’re still part of the world and we’re making a difference, and we are learning and we’re engaged.