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Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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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

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.

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

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). The article stated that each of the thirty-three individuals had no known asbestos exposure other than talcum powder. That article has “junk science” red flags flying all over it. So Dr. Moline set out to fill that void.

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Informed Consent Fraud FDA HIPAA 59