NHLBI Small Biz Hangout: Biologics Regulation Overview

Watch this NHLBI Small Biz Hangout webinar to learn about the process of developing a new biologic product. You’ll follow a hypothetical case study that pulls together the various stages of biologics development to describe one potential product development pathway.

This video is by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).

Chapter 1: Introduction 00:00
Chapter 2: What is a Biologic? 03:24
Chapter 3: FDA Review of Biologics 04:26
Chapter 4: Biologics Investigational New Drug Requirements 07:20
Chapter 5: IND Maintenance 15:55
Chapter 6: Special Programs for Biologics 23:56
Chapter 7: Biologics License Applications 30:08
Chapter 8: Case Study 36:59
Chapter 9: Questions and Answers 48:16
Chapter 10: Contact Information 50:54