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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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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions.

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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. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Tasce: Right.

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

GeriPal

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. So our elders who are people of color, people who live in places that are already challenged by poor air quality and those things and access to healthcare, they also have greater risks. Ruth: Yeah. Ruth: Yeah.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. 149, 158 (2014). Such a message may understandably deter the targeted conduct to avoid such a risk. Anthony List v. Driehaus , 573 U.S.