Remove 2019 Remove Government Remove Manufacturing Remove Physicals
article thumbnail

Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

FDA Law Blog

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. District Court, which sided with Genus in December 2019.

article thumbnail

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

AFP 2019 Gabapentin for chronic neuropathic pain in 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. We should be able to trust all the data that comes from our governing board.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. Even a basic understanding of chemistry, biology, and physics is enough to debunk the concepts in this pseudoscience.

article thumbnail

Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!

FDA Law Blog

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. is safe, legitimate, and honestly made.