Navigating New Terrain in Advertising and Promotion of Medical Products - Webinar CD/Transcript
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Navigating New Terrain in Advertising and Promotion of Medical Products: A Practical Approach to the New Communications and Off-Label Landscape
The rules on drug and device marketing are changing. In the absence of settled policy, your safe harbor lies in following the terms of three draft FDA guidances.
You could hire high-powered Washington lawyers to help you out, at a cost of thousands of dollars per hour. Or you could sign up now for this new webinar from FDAnews that lets you pick those lawyers’ brains ... for a pittance.
In 90 fast-paced minutes, Lisa M. Dwyer, Partner, and Heather Bañuelos, Counsel — from King & Spalding, one of Washington’s top FDA regulatory practices — will decipher the three guidances that are the closest thing to FDA policy now available:
- Draft Guidance: Medical Product Communications That Are Consistent With the FDA-Required Labeling
- Draft Guidance: Communications With Payors, Formulary Committees, and Similar Entities
- Draft Guidance: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
You’ll discover the plain-English meaning and application of:
- What “consistent communications” means vs. on-label and off-label communications ...
- How the FDA interprets the “three factor test” for consistent communications and how to apply it in practice ...
- How to evaluate consistent communications as “scientifically appropriate and statistically sound” ...
- The real-life scope of the new safe harbor for pre-approval communications with payors ...
- The everyday application of the concept “healthcare economic information” to your products ...
- How to consider the context of your communications to ensure adequate disclosure of information (e.g., study designs, limitations, disclaimers, etc.) ...
- And much more!
Marketing communications are a must for the success of your products. But the rules can be a minefield. This session makes them clear. Order today.