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

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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

Informed Consent

Informed Consent FDA Compliance Regulatory Compliance

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. This is where FDA’s Emergency Use Authorization (EUA) comes into play and offers an opportunity for the medical industry to rally and help.

US Department of Health and Human Services

US Department of Health and Human Services FDA Public Health COVID-19

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

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

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