FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Manufacturing 59

Manufacturing Government IT Provider 59

FDA Law Blog

APRIL 19, 2021

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.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. Almost all recalls are conducted on a voluntary basis by the manufacturer. The Guidance emphasizes that firms need to be “recall ready.”

Electronics 40

Electronics Manufacturing Provider IT 40

GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? 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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. What do we do to very concretely provide heat shelters and cool shelters? And when I was born, people didn’t live past their sixties.

Healthcare 129

Healthcare IT Education Community 129