Communicating Beyond the Label: FDA's Latest Guidance & Updates

Date: March 9, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

Prescription drug and device manufacturers are only permitted to market their products for the specific uses and populations approved by the FDA. Yet, manufacturers have much more information about their products, and in some cases, their products are being used extensively in ways that are not described in their labels. Just recently, FDA released two guidances and a draft memorandum describing what manufacturers may do (and may not do) to communicate this information to healthcare providers, consumers, and payors.

Join our interactive online training course where you will learn:

  • What information FDA views as “consistent with” the approved product label
  • Which preapproval communications FDA views as permissible
  • The types of information companies can share with payors
  • Likely developments from the FDA on off-label communications
  • FDA’s clarification of healthcare economic information (HCEI) and FDAMA 114

This course will be of benefit to anyone involved in commercialization and FDA submissions. The content is tailored to have the greatest value for:

  • Senior commercial leadership
  • FDA regulatory professionals
  • Legal and medical personnel responsible for promotional review
  • Marketers of prescription products (pharmaceuticals, biologics, devices, and vaccines)
  • Advertising agency personnel who promote prescription products
  • Marketing services personnel responsible for review and approval procedures
  • Compliance personnel
  • Medical affairs

Dale Cooke is owner of PhillyCooke Consulting, which provides advice and training to companies about developing compliant promotional materials for FDA-regulated products. Dale has worked with more than 30 pharmaceutical and medical device clients around the world. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA. 

Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI’s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media.

Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona. He studied Epidemiology and Biostatistics at Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall University’s School of Law.