Health Law Advisor

SEPTEMBER 5, 2023

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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.

Informed Consent 52

Informed Consent FDA 52

Bill of Health

AUGUST 29, 2022

They are at the mercy of authority figures from multiple systems—the judiciary, government officials who oversee their day-to-day health, safety, and wellbeing, parents or legal guardians who may retain control over their bodily autonomy and decision making, and service providers who have access into the story of their lives. & Fams.,

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Drug & Device Law

FEBRUARY 29, 2024

Providence Health & Services , No. Covered countermeasures” include “qualified pandemic or epidemic product[s]” so designated by a declaration of the Secretary of Health and Human Services. And that brings us to the Public Readiness and Emergency Preparedness Act (or “PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e. 3d __, 2024 U.S.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59