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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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.
Blog Editors
Recent Updates
- The Proposed HHS Budget for 2027: Key Takeaways
- Contractor to Pay More Than $17 Million in First DOJ False Claims Act Settlement Alleging Illegal DEI
- Listen: DOJ’s Bulk Sensitive Data Transfer Rule: Key Insights for Health Care Compliance Teams – Diagnosing Health Care
- FDA Launches Home Innovation Challenge for Medical Device Technologies
- FDA Meeting Invites Stakeholders to Weigh in on Dietary Supplement Ingredients