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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

Informed Consent 52

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

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]

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

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

Drug & Device Law

FEBRUARY 29, 2024

The plaintiffs alleged that the decedent had been hospitalized for COVID-19 and treated with the defendants’ antivirals without adequate informed consent, and passed away after three weeks. They did not, however, contest that defendants were “covered person[s]” or that the antiviral medications were “covered countermeasures.”

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

AUGUST 22, 2022

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. Mentor Worldwide LLC , 2014 WL 6390307 (D.S.C. 23, 2014); Malonzo v. Mentor Worldwide, LLC , 2014 WL 2212235 (N.D. May 28, 2014); Couvillier v.

Informed Consent 59

Informed Consent FDA Doctors 59

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.

FDA 59

FDA Doctors Malpractice Informed Consent 59