Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.

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Healthcare Law Blog

AUGUST 9, 2023

The bill amends the existing Women’s Right to Know Act with the expansion of the definition of abortion. The information included in this article is current as of August 1, 2023, but it does not address all potential legal issues or jurisdictional differences, and the information presented may no longer be current. [1]

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Licensing Informed Consent Nurses FDA 52

Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Nor could a trade association be liable for common-law negligence in either jurisdiction: “[P]ublication of testing standards and ingredient definitions did not create any legal duty to the general public.”

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Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). While the compensation claims did “not definitively establish” other asbestos exposure, plaintiff “nonetheless made statements. . ., 11-17 (Jan. may well be factually applicable to Dr.

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Drug & Device Law

MARCH 9, 2022

Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. No Informed Consent.

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