Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications
This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more
In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more
On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more