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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

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Informed Consent FDA 52

Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.

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Informed Consent FDA Compliance Regulatory Compliance 40

SQA

APRIL 30, 2021

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Bill of Health

AUGUST 29, 2022

Bureau 1, 2 (2014); Robert B. 8] Young people under age 18 in California detention centers need parental consent to receive the vaccine. Omicron Surge , Bloomberg (Dec. 31, 2021), [link] (describing a record number of pediatric COVID-19 hospitalizations due to the omicron variant). [2] & Fams., 3] Bell, supra note 99 at 26. [4]

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Drug & Device Law

JUNE 6, 2022

Abbott Laboratories , 2014 WL 4197494, at *7 (C.D. July 29, 2014) (no causation where the prescriber “testified that had he been aware” of what plaintiff alleged, “he still would have prescribed”); Mattson v. 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 3d 501 (8th Cir.

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FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

JANUARY 28, 2022

She sued the gynecologist, not the surgeon who implanted the mesh, for failing to obtain informed consent for the implant. Similarly, the plaintiff must show the safety benefits from the proposed design are foreseeably greater than the resulting costs, including diminished usefulness or diminished safety.” at *20 (citing Casey v.

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Informed Consent Malpractice Compliance 59

Drug & Device Law

MAY 30, 2022

2014 WL 3798338 at *17 (N.J. 4, 2014) (applying California law). “In 2014 WL 4930675, at *3 (N.D. 2014 WL 4930675, at *3 (N.D. 1, 2014) (no causation where prescriber “knew of the risks associated with [the drug], yet felt the benefits outweighed the risk”) (applying Oregon law); Schmitt-Doss v. 3d 878, 891 (W.D.

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Doctors Licensing Informed Consent Hospitals 59