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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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
- DOJ’s Final Rule on Bulk Data Transfers: The First 180 Days
- California Governor Signs SB 351, Strengthening the State’s Corporate Practice of Medicine Doctrine
- No Remuneration Plus No "But-For" Causation (Between an Alleged Kickback and Claims Submitted to the Government) Means No FCA Violation, District Court Says
- Novel Lawsuits Allege AI Chatbots Encouraged Minors’ Suicides, Mental Health Trauma: Considerations for Stakeholders
- DOJ Creates Civil Division Enforcement & Affirmative Litigation Branch: Implications for Health Care and Beyond