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

On August 15, 2023, the U.S. 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 This update follows FDA’s draft guidance, which was issued in July...more

Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care [Video]

The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the...more

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