Posts tagged Andrew Rusczek.
Blogs
3 minute read
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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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 ...
Blog Editors
Recent Updates
- Podcast: 42 CFR Part 2 Final Rule: What’s Changing and What Do You Need to Know? – Diagnosing Health Care
- Congress Creates Yet Another Cliff for Medicare Telehealth Extensions (and We’re Running Out of Metaphors)
- OIRA Memo on Agency Deregulation: Implications for Health Care
- Outside Counsel’s Internal Investigations—Including Those Relating to Health Care—Are Privileged and Protected from Disclosure
- Podcast: Current Tailwinds in Women’s Health - What Do They Mean for Your Business? – Diagnosing Health Care