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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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.

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

Bill of Health

325, 338 (2005). [21] Barnette , 319 U.S. 624, 63 S.Ct. 1178.”); Kelsi Brown Corkan, Free Exercise in Foster Care: Defining the Scope of Religious Rights for Foster Care Children and Their Families , 72 U. 21] Colby, supra note 206, at 55. [22]

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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. . . 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 3d 812, 816 (11th Cir.

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