Loading...

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

2,640 views

Loading...

Loading...

Transcript

The interactive transcript could not be loaded.

Loading...

Loading...

Rating is available when the video has been rented.
This feature is not available right now. Please try again later.
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

  • Category

  • License

    • Standard YouTube License

Loading...

When autoplay is enabled, a suggested video will automatically play next.

Up next


to add this to Watch Later

Add to

Loading playlists...