Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

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Health Populi

MAY 30, 2018

consumers’ views on personalized medicine comes from a survey conducted for PMC, the Personalized Medicine Coalition, and GenomeWeb , published in May 2018. This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. This picture of U.S.

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Informed Consent FDA Health Insurance HIPAA 69

Drug & Device Law

NOVEMBER 28, 2022

2018) (Etminan); Gerke v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Zambelli-Weiner); In re 3M Bair Hugger Litigation , 924 N.W.2d 2d 16, 19 (Minn. 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 316, 328-29 (D.

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Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).

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Informed Consent FDA Doctors 59

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. April 26, 2018); Cooper v. 3d 1223, 1233 (11th Cir.

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FDA Doctors Malpractice Informed Consent 59