NHLBI Small Biz Hangouts: Conquering the (Regulatory) Basics | Navigating the FDA Website





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Published on Apr 7, 2014

How do biomedical innovators begin to understand how FDA may regulate their novel technology? It turns out there is a lot of useful information on FDA’s website – if you know how and where to look. You can find out how the FDA is organized, and where your technology is likely to be reviewed; access (redacted) approval documentation for similar technologies to help inform your development strategy, and find resources – including guidance documents, webinars, slide decks, and case studies – developed to help innovators understand FDA’s regulatory approach.

Chapter 1: Introduction 00:00

Chapter 2: Learning Objectives 02:33

Chapter 3: Website demonstration FDA homepage 04:56

Chapter 4: Website demonstration LEARN pages 08:11

Chapter 4: Website demonstration Guidance Documents 12:12

Chapter 5: Website demonstration FOIA Reading Rooms 13:28

Chapter 6: Small Business Office and Key Staff Contacts 21:35

Chapter 7: Q & A 32:30

Chapter 8: Signing up for Updates 33:54

Chapter 9: Q & A 38:04

Chapter 10: Website list and Contact Information 45:46

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