Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more