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NHLBI Small Biz Hangout: First Contact with FDA

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Published on Jul 24, 2014

FDA often says “come early, come often” to biomedical innovators – but when and how to reach out to the Agency is often confusing to those new to developing life science technologies. In this webinar both formal and informal methods for early communication are discussed by two professionals - each with more than 15 years of experience developing technologies across CDER, CBER, and CDRH. Case Studies are used to examine situations where different approaches are appropriate.

Chapter 1: Introduction 00:00

Chapter 2: CDER/CBER Pre-IND Process 03:38

Chapter 3: CDRH Presubmission Process 20:01

Chapter 4: Early Interactions Q & A 45:03

Chapter 5: Small Business Resources at FDA 50:51

Chapter 6: Case Studies 55:37

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