Legal, Compliance and Regulatory Forum: Commissioner Califf’s “Going Away” Presents: FDA Final Rule & Draft Guidances to Transform Product Communications
Legal, Compliance & Regulatory Forum*
Commissioner Califf’s “Going Away” Presents: FDA Final Rule & Draft Guidances to Transform Product Communications
TUESDAY, MARCH 28, 2017
Drinker, Biddle & Reath | 600 Campus Drive | Florham Park, NJ 07932
Registration is open only to BioNJ Innovation Company Member Professionals, as well as Market Maker, Preferred, Executive and Institutional BioNJ Members.
Future BioNJ Innovation Member fee is $50.
Times are Changing: In the waning days of the Obama Administration, the FDA issued several historic documents that transform how pharmaceutical, biologic and medical device companies communicate about their products. These updates include two draft guidances, a First Amendment memo and the Final Rule on “Intended Use.”
- How are companies altering their approach in light of FDA’s draft guidances (e.g., promotion of subgroup analysis, pre-approval payor communications)?
- What new types of scientific data are now “in play” for promotional claims?
- How much contextual information is really necessary?
- How must companies adapt?
8:00 a.m. – 8:30 a.m. Registration & Networking Breakfast
8:30 a.m. – 10:30 a.m. Program
10:30 a.m. – 11:00 a.m. Networking
Join us for an interactive discussion including real-life scenarios that will consider the practical implications for payor communications, promotional messaging and off-label communications.