Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016

I will be Speaking at FDA's Part 15 hearing on"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products" on 9 November, 2016 (read"FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion").The purpose of this meeting is to obtain"input on issues" related to off-label product communications about by pharmaceutical and medical device companies (seehere). I will presenting the preliminary results of myDirect-to-Consumer Off-Label Promotion Survey in my allotted time of 8 minutes.Here's the list of speakers:Wednesday, 9 NovemberWelcome and Administrative AnnouncementsLeslie Kux, Associate Commissioner for PolicyOpening RemarksDr. Robert Califf, CommissionerMr. Jeffrey Francer, Pharmaceutical Research and Manufacturers of America (PhRMA)Ms. E. Cartier Esham, Biotechnology Innovation Organization (BIO)Ms. Khatereh Calleja, Advanced Medical Technology Association (AdvaMed)Ms. Kellie Combs, Ropes& Gray LLPMs. Coleen Klasmeier, Sidley Austin LLPMr. James Czaban, DLA Piper LLP (US)Mr. Daniel Biank, DuVal& Associates, P.A.Ms. Sandra Kalter, Medtronic PLCMs. Esther Carbon, RTI Surgical, Inc.Ms. Danelle Miller, Roche DiagnosticsDr. Sandra Milligan, MerckMrs. Penny Levin, Teva PharmaceuticalsDr. Edith Perez, Genentech Mr. Frank Wilton, American Association of Tissue Banks (AATB)  Mr. Nicodemo Fiorentino, G&M Health, LLCMs. Zoe Dunn, Hale AdvisorsMs. Tracy Rockney, OneSource Regul...

Source: Pharma Marketing Blog - October 24, 2016 Category: Pharmaceuticals Tags: FDA off-label promotion Public Hearing Source Type: blogs