Lexology November 30, 2022
As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.
Promotion of Emergency Use Drugs
- Overview of Emergency Use Authorization
Under the Food Drug and Cosmetic Act (the “FDCA”), FDA may authorize unapproved medical products, including drugs, for use in an emergency to diagnose, treat,...