In this webinar...
Off-label communications have always represented a challenging area for the regulated industry. However, recent Court decisions have come down in favor of less government restriction of commercial speech. In the wake of these cases, the FDA convened a public hearing in November 2016 and has since issued two important draft guidance documents that address some, but certainly not all, issues regarding information that companies can proactively communicate outside the information expressly contained in a product’s approved full prescribing information. During this webinar we will examine these recent developments and consider where companies might consider altering their traditional policies and where it may be prudent to continue exercising caution.
- Michael Labson, JD, Partner, Covington & Burling LLP
- Mark Gaydos, Vice President, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs, Sanofi