Paul Gadiock to Present a FDLI Webinar on Off-Label Communications
Arent Fox FDA senior attorney Paul Gadiock will be presenting a webinar through the Food and Drug Law Institute on Thursday, March 16, 2017. In light of FDA’s recent public hearing on off-label communications, on January 18, FDA released two draft guidance documents and one memorandum to address FDA’s current thoughts on communicating health care economic information to payors, consistent-with-label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. The webinar will explore whether these documents illustrate a change of course for FDA, indicate a path for the future, or leave unanswered questions, as well as the First Amendment implications. This webinar will also provide insights on how these two draft guidance documents might be implemented and the potential effect for drug and medical device companies. The draft guidance documents are open for comment until April 19, 2017. Click here to learn more about the webinar.