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

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. 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. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin).

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 7, 2023

And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. 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.

Healthcare 129

Healthcare IT Education Community 129