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). & Mfrs.
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.
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FDA Law Blog
MARCH 20, 2022
Almost all recalls are conducted on a voluntary basis by the manufacturer. Firms also need to maintain distribution records to facilitate identifying the direct accounts that received the recalled product by name, physical address where the product was delivered, and contact information.
GeriPal
MARCH 2, 2023
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. So that’s kind of how it first came on my radar.
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. But Ruth, I was wondering too, and you invited us to ask each other questions, so my golly I’m going to do it.
Tiny Physician
OCTOBER 17, 2021
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. To send a DM, use Telegram.
FDA Law Blog
MAY 8, 2025
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.
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