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Session 10: OPDP Core Launch Review -FDA and Industry Perspectives
Session Chair(s)
Sheetal Patel, PharmD
Vice President, Specialty Compliance
Johnson & Johnson, United States
Virginia Foley
VP Regulatory, Life Sciences & Healthcare
Constellation, Inc., United States
Come join FDA-OPDP staff along with industry experts, each with unique perspectives, as they discuss best practices and strategies of a Request for Advisory Comments submission and how they apply to Direct-to-Consumer (DTC) broadcast advertisements, new product launches and accelerated approvals (subpart E/H), and press releases. We will also discuss the various pathways for submitting a Request for Advisory Comment, both in eCTD and non-eCTD format, as well as delving into some recommendations to help Sponsors construct Advisory submissions.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the chronological events involved in the development and review of launch advisory submissions
- Identify best practices in the development, construction, submission and review of a Request for Advisory Comment submission
- Define "What good looks like" in a strategic submission seeking FDA Advisory Comments (DTC Broadcast, new product launches, accelerated approval, press release)
Speaker(s)
Speaker
Jason Cober, MPA
ProPharma Group, United States
Lead Project Manager
Speaker
Rachael Elizabeth Conklin, MS
FDA, United States
Senior Consumer Safety Officer
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