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
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more