Keeping Up with FDA’s Off-Label Use Policy

FDAnews

Promotional Communication:

Keeping Up with FDA’s Off-Label Use Policy

**An FDAnews Management Report**

http://www.fdanews.com/products/54818-promotional-communication    

In the competitive world of drug and device marketing and promotion, drug and devicemakers need every edge they can get while staying in compliance with FDA rules.

The FDA has issued two draft guidances that are the closest thing to FDA policy that exists at the moment, but the agency isn’t done yet.

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy explores the draft guidances and other FDA activity on the subject of promotional communication explaining what companies must do to stay on the right side of the agency’s new policies and importantly how to take advantage of the opportunities they present. Readers will learn:


  • How the FDA’s amendments to the “intended use” regulation has changed the landscape
  • What “consistent communications” means versus “on-label and off-label communications”
  • The “three-factor test” for consistent communications and how it is it applied in practice
  • How to evaluate consistent communications as “scientifically appropriate and statistically sound”
  • What’s the real-life scope of the new safe harbor for pre-approval communications with payers
  • How manufacturers should consider the context of their communications to ensure adequate disclosure of information (e.g., study designs, limitations, disclaimers, etc.)

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy provides manufacturers with a clear understanding of what promotional speech about off-label uses the FDA will allow.

Who Will Benefit:

  • Legal
  • Compliance
  • Regulatory
  • Marketing/Commercial
  • Medical Affairs
  • Clinical Affairs/R&D

FDAnews Management Report Details:

Promotional Communication:

Keeping Up with FDA’s Off-Label Use Policy

Price: $397

http://www.fdanews.com/products/54818-promotional-communication        

Easy Ways to Order:

Online:     http://www.fdanews.com/products/54818-promotional-communication            

By phone: 888-838-5578 or 703-538-7600

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