FDA Law Blog

AUGUST 21, 2023

Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false. But we digress.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

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. Eric: So as we start talking about things that we can do about it, maybe we can just start off with this thing of including it in the curriculum for healthcare professionals.

Healthcare 129

Healthcare IT Education Hospital 129