FDA Law

NOVEMBER 1, 2023

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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. 2014); U.S. Stem Cell Clinic, LLC , 998 F.3d 3d 1314 (D.C.

Clinic 59

Clinic Patient-Centered Asthma Patients 59

FDA Law

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. User facilities are not required, but have been encouraged, to submit MDRs electronically.

Electronics 59

Electronics Manufacturing Provider Medical 59

GeriPal

MARCH 2, 2023

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. I understand that it can be a hard place clinically.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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.

Healthcare 129

Healthcare IT Education Community 129