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FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Health Law Advisor

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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.

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Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

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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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

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.

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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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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Guest Post – Curling Up With a Good Reasonable Alternative Design Opinion

Drug & Device Law

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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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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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