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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 Lead, Life Sciences & Healthcare
Constellation, 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
OPDP | OMP | CDER | FDA, United States
Lead Project Manager
Speaker
Rachael Elizabeth Conklin, MS
FDA, United States
Senior Consumer Safety Officer
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