FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). The government asserted additional allegations that are outside our scope. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. Zarzamora Press Release.

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Treatment Plan ER Government Patient-Centered 139

Physician's Weekly

JUNE 24, 2025

has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. The new studies are coming at a fraught political moment. The nation’s health secretary, Robert F. Kennedy Jr.,

Vaccination 52

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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While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). E6(R3) specifically acknowledges the rise of innovative trial designs such as adaptive and decentralized methods, while also encouraging the use of electronic informed consent and remote monitoring.

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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

FDA counsels that, as is the case with any other electronic device, seemingly small, routine steps like software maintenance and updates are ways companies can address possible vulnerabilities that could lead to adverse events. More updates will follow here as trends develop in 2023.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

SEPTEMBER 17, 2023

Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. Additionally, recent visitors did not have to scan their identification cards through an electronic machine. Green card holders will be asked to show their permanent resident card.

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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. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

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Provider Medical Complication Diabetes 109