Slipping Through the Cracks:
Are you making the common mistake of improperly applying the Interactive 2253 Guidance for social media and digital content submissions? How much do you know about the FDA’s exceptions to the Form FDA2253 submission requirement for certain types of regulatory documents?
Don’t miss “Slipping Through the Cracks: Insider Insights on 2253’s.“
You’ll learn:
- Which guidances provide exceptions to the 2253 submission requirement
- What exceptions the new SIUU Final Guidance provides for Medical Affairs communications
- Dos and don’ts of applying the Interactive 2253 guidance
- How to use the recommendations in the Addressing Misinformation Guidance to respond to inaccuracies about your products in AI summaries and commercial AI model outputs
- 2253 submission requirements when addressing misinformation about your product
Plus, Jason has set aside 30 minutes to answer audience questions. Register now to save your seat!
ABOUT SPEAKER JASON COBER
Former FDA/OPDP Lead Project Manager
Jason Cober is the former Lead Project Manager in the FDA’s Office of Prescription Drug Promotion (OPDP). Jason joined the FDA in 2008 and served in this role from 2016 until 2025, working closely with industry on digital, modular, and GenAI content submissions. He has over 15 years’ experience with the Agency’s electronic Common Technical Document (eCTD) specification and guidance development. At OPDP, Jason led the office’s eCTD outreach efforts, supporting industry compliance and regulatory clarity for promotional submissions.
About the Insider Insights Webinar Series
Hale Advisors developed the Insider Insights webinar series to fill the gap in OPDP information and access created by the April reduction in force (RIF). The series focuses on essential pharmaceutical advertising and promotion compliance topics, with each session delivering critical information and insight along with a 30-minute forum for audience questions.
