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February 8, 2012

Standardization of REMS in the Customized Healthcare Marketplace

Standardization is a central element of many recent presentations by FDA on future directions for Risk Evaluation and Mitigation Strategies (REMS).  The opportunities for greater standardization of criteria, methods, and/or tools are many, including:

  • Criteria for deciding whether a REMS is needed as well as what elements of a REMS are necessary
  • Content and formatting of certain REMS materials
  • Prescriber educational methods

This webinar provides essential insights for individuals responsible for the design, regulatory documentation, and/or operation of risk mitigation and REMS programs regarding existing and anticipated standards.


  • Review recent communications and presentations by FDA related to REMS standardization
  • Review existing standards and identify areas where greater standardization may evolve in the future
  • Evaluate recent examples illustrating the emerging use of more standardized approaches in the FDA review of and/or direction for Proposed REMS programs


  • Jeff Fetterman – President, ParagonRx


Webinar Slide Set:




Session Replay:

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call 888.459.8080 or email