FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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Electronics Manufacturing Provider Medical 59

FDA Law

OCTOBER 14, 2024

2014); U.S. The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d 3d 1302 (11th Cir.

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FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. AFP 2019 Gabapentin for chronic neuropathic pain in adults.

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GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. 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. Leslie: Well, yes, thank you, Ruth. Ruth: Right. Ruth: Yeah.

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FDA Law

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 149, 158 (2014). Anthony List v. Driehaus , 573 U.S.

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