Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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FDA Informed Consent COVID-19 Fraud 40

Healthcare Law Blog

MARCH 17, 2022

Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

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US Department of Health and Human Services Informed Consent Medicare Medicare 52

Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. Blue Shield of California is counting on it. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

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US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

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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FDA Fraud Informed Consent 52

Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. Such power rests solely with the FDA.” Typically overblown MDL claims for “fraud” and “conspiracy” also failed.

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Doctors Fraud Licensing Compliance 52

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). Jaqueline Moline, and her increasingly questionable paper “Mesothelioma Associated with the Use of Cosmetic Talc,” 62 J. 11-17 (Jan.

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Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

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FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105