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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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
- A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway
- Imports and the DOJ’s Trade Fraud Task Force: Considerations for the Health Care and Life Sciences Industries
- Federal Appellate Court Upholds Mississippi 340B Contract Pharmacy Protections
- DOJ False Claims Act Priorities: Cybersecurity Is Still on the Radar
- DOJ Launches Cross-Agency Trade Fraud Task Force: What Importers and Businesses Need to Know