Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and...more