FDA Guidance on Off-Label Communication, Part 1

Medtech Matters

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.

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