Medtech Matters

FDA Guidance on Off-Label Communication, Part 1


Listen Later

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about off-label communication. More specifically, we’re reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed:

  • Can you first please provide an explanation of what “off-label” is in terms of the FDA?
  • Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?
  • What’s new in this “final” guidance?
  • What is meant by firm-initiated communication containing scientific information on unapproved uses?
  • If you communicate with an organization about unapproved (or off-label) uses, what will happen?
  • If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?
  • Does FDA need to know about the communication?
  • What else is important?
  • What are the most important takeaways?

Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this discussion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Send us a text

For more medtech news and information, visit https://www.mpomag.com.

...more
View all episodesView all episodes
Download on the App Store

Medtech MattersBy Medical Product Outsourcing

  • 4.8
  • 4.8
  • 4.8
  • 4.8
  • 4.8

4.8

5 ratings


More shows like Medtech Matters

View all
Freakonomics Radio by Freakonomics Radio + Stitcher

Freakonomics Radio

32,260 Listeners

Medsider: Learn from Medtech and Healthtech Founders and CEOs by Scott Nelson

Medsider: Learn from Medtech and Healthtech Founders and CEOs

67 Listeners

Global Medical Device Podcast powered by Greenlight Guru by Greenlight Guru + Medical Device Entrepreneurs

Global Medical Device Podcast powered by Greenlight Guru

92 Listeners