FDA and Pediatric Approval

Description

This session will explore the relationship of the FDA and the Pediatric medical community and provide a forum for discussion.

Learning Objectives

Summarize the history of the FDA in pediatrics and why it matters.
Describe opportunities to be involved, how the FDA works, and who our contacts can be at the FDA level.
Explore future directions for interactions with the FDA and how best to advocate for pediatric and ACHD patients.

Session Chair(s)

Elizabeth Saarel, MD
Rohan Kumthekar, MD

Presentations

What does it take to get something FDA approved in Pediatrics?
Presenter(s): Charles I. Berul, MD

TED Talk: History of FDA and Pediatrics
Presenter(s): John K. Triedman, MD

How can PACES advance Pediatric and ACHD device development for FDA approval?
Presenter(s): Anne M. Dubin, MD

Why is it important to have FDA approval in Pediatric and ACHD?
Presenter(s): George F. Van Hare, MD

Disclosures

Charles Berul:

Medtronic,Inc. (Research (Contracted Grants for PIs and Named Investigators only))
PeriCor, LLC (Ownership/Partnership/Principal)

John Triedman:

UpToDate, Inc. (Royalty Income)
SentiAR, Inc. (Honoraria/Speaking/Consulting Fee)
Biosense Webster, Inc. (Institutional payments for provision of technical training)

Anne Dubin:

UpToDate, Inc. (Royalty Income)

George Van Hare: Nothing Relevant to Disclose

To view all Heart Rhythm 2023 Faculty Disclosures, please click here.

Education Framework

Bradyarrhythmias
Pacemakers
n/a – non-clinical content
General Concepts
Communication Skills and Shared Decision Making

Summary


Availability:	On-Demand


Cost:	FREE


Credit Offered:	No Credit Offered