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August 13, 2014

FoREMS & More: Communicating New Risk Information: A Review of the New FDA Draft Guidance

12 pm New York time, 9 am California time, 5 pm London time

In June 2014, FDA issued new draft guidance describing the Agency’s thinking on recommended practices for drug manufacturers and their representatives to follow if they choose to distribute scientific or medical journal articles to health care professionals or health care entities that describe new risk information for approved prescription drugs.  One set of insights offered by this guidance is the pragmatic practice for disseminating new risk information.  Another set of insights that is highly relevant from the perspective of a risk management professional is the detailed description of FDA risk assessment, pre-and postmarket, that is provided in Section III of the guidance.  This guidance provides important knowledge for all risk management professionals. 


  • An overview of the new draft guidance:  Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices
  • A detailed evaluation of how FDA describes the risk assessment of drugs in the pre- and postmarket lifecycle
  • Recommendations for conducting a systematic risk assessment as part of a medical communications strategy
  • A discussion of the nature of evidence that is needed to support new risk information
  • Regina Ruben, PhD – Director, Clinical Consulting, ParagonRx
  • Lee Walke – Executive Director, Late Stage Analytics, inVentiv Health Clinical
  • Stephen Sun, MD, MPH – Chief Medical Officer, ParagonRx

To view the recording of this webinar, click here.

To download a copy of the slides from this presentation, click here.

To view the guidances mentioned during this webinar, see below:

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