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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
In this episode of the Diagnosing Health Care Podcast: 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 nation with respect to abortion services.
What additional implications are there for certain aspects of clinical trials and research?
On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.
Recent Updates
- GLOBE Model Final Rule Drops — But Will It Work on a Smaller Scale?
- Congressional Action on Health Care Cybersecurity: HISAA is Re-Introduced and the Health Care Cybersecurity and Resiliency Act Moves Forward
- DOJ Corporate Fraud Enforcement Memo: What Health Care Companies Need to Know Now
- Attorneys General of Three States File Two Sweeping Lawsuits Targeting Telehealth Abortion Providers and State Shield Laws
- RFI Seeks Input on Medicare Part D’s Pharmacy Contract Standards