Medical Device Legal News with Sam Bernstein: Episode 11
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The ACCC sets out best marketing practices and companies’ obligations under the Australian Consumer Law, including strict penalties that may follow. In July 2023, the Australian Competition and Consumer Commission (ACCC)...more
What will adult-use cannabis products look like in New York? As of June 1, 2022, we can finally answer that burning question. The NY Cannabis Control Board voted yesterday to approve draft regulations for Adult-Use Packaging...more
Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more