Anisa Mohanty

Sep 6, 2023 | jdsupra.com | Jennifer S. Geetter |Anisa Mohanty |Sam Siegfried

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.

Sep 6, 2023 | lexology.com | Jennifer S. Geetter |Anisa Mohanty |Sam Siegfried

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.