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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

FDA 40

FDA Informed Consent COVID-19 Fraud 40

Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

COVID-19 98

COVID-19 Informed Consent FDA Licensing 98

Healthcare Law Blog

AUGUST 9, 2023

The now-active provisions include a prohibition on abortions after 12 weeks of pregnancy (with limited exceptions), 72-hour informed consent requirements, pre-abortion gestational age verification, and reporting requirements for abortions after 12 weeks. [21] United States FDA , 2023 U.S. for Hippocratic Med. 7, 2023). [2]

Licensing 52

Licensing Informed Consent Nurses FDA 52

Drug & Device Law

JUNE 14, 2023

Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day. There is no carve-out for informed consent. And therein, in a strange way, lies our interest in Francisco v. 2023 WL 3589654 (Ariz.

FDA 59

FDA Malpractice Informed Consent Doctors 59