FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). By Larry K. Zarzamora Press Release.

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Treatment Plan ER Government Patient-Centered 139

Physician's Weekly

JUNE 24, 2025

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. “I’m sort of hectoring,” she acknowledged. The nation’s health secretary, Robert F.

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Vaccination Illness Hospital Patient-Centered 52

FDA Law Blog

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.

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Clinical Practice Clinic Government Management 88

FDA Law Blog

OCTOBER 7, 2024

27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. H&P specifically relies on the Supreme Court decision in Jarkesy , as well as the 2023 Supreme Court decision in Axon Enterprise, Inc.

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Electronics IT Government Provider 59

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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Patient-Centered Manufacturing Provider Telehealth 59

FDA Law Blog

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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Screening Transportation Provider Electronics 59

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The content is provided for information purposes only. But technical limitations have made it hard to understand how neurons in this area form functional circuits." Your feedback is important to us.

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