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
The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more
On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more
3/29/2022
/ AdvaMed ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Ethics ,
Final Rules ,
Health Care Providers ,
Healthcare Workers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Technology Sector ,
Value-Based Care
The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more
The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics -
The Advanced Medical Technology Association (AdvaMed) published in late December 2018 an updated version of its widely-adopted...more
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more