The Pharma Data

AUGUST 28, 2020

The Department of Health and Social Care (DHSC) said this could include training a wider range of existing NHS staff, as well as student doctors and nurses. The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. A few people died in those early challenge trials, though, including a nurse named Clara Maass , who was challenged multiple times. Ultimately, I don't think that they are mutually exclusive.

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. And Mary-Anne, a nurse from Arkansas, who says…. My doctor said it was all simple math…. And the energy, my god.

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

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Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

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