In light of FDA’s recent public hearing on off-label communications, on January 18, FDA released two draft guidance documents and one memorandum to address FDA’s current thoughts on communicating health care economic information to payors, consistent-with-label communications, and communications regarding unapproved uses of approved medical products.

  • Do these documents illustrate a change of course for FDA, indicate a path for the future, or leave unanswered questions?
  • What are the First Amendment implications?

This webinar will discuss these questions, as well as insights on how these two draft guidance documents might be implemented and the potential effect for drug and medical device companies. The draft guidance documents are open for comment until April 19, 2017.

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Speakers

Kristin Davis | Read Bio
Senior Policy Analyst, Office of the Commissioner, FDA

Paul Gadiok | Read Bio
Senior Attorney, Arent Fox LLP

Kellie Combs | Read Bio
Partner, Ropes & Gray LLP

Moderated by
Joy Liu | Read Bio
VP, Commercial and Regulatory Legal, Vertex Pharmaceuticals, Inc., and Secretary and General Counsel, FDLI Board of Directors

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