Resources

Webinars

Return to listings page

March 9, 2011

Wednesday FoREMS: Our “Guidance” on the New FDA Draft Guidance for MedGuides in REMS This webinar we will review the newly issued FDA draft guidance for MedGuides in REMS, explore implications for you and your product, and discuss the new, unexpected, and interesting insights

Our “Guidance” on the New FDA Draft Guidance for MedGuides in REMS

On February 28, FDA issued Draft Guidance for Industry:  Medication Guides – Distribution Requirements and Inclusion in REMS. In addition to other topics, this guidance addresses how a Medication Guide will be required as part of a REMS.  Given that 67% of all REMS programs include only MedGuides and Assessments as program elements, the implications of this draft guidance are essential knowledge for industry professionals and this  will be the focus of this month’s Wednesday FoREMS webinar, held March 9th at 12 noon EDT.

Topics:
  • Review provisions of Draft Guidance
  • Implications and commentary
  • Recommendations

In this webinar we will review the newly issued FDA draft guidance for MedGuides in REMS, explore implications for you and your product, and discuss the new, unexpected, and interesting insights.

Presenters:

  • Jeff Fetterman, President – ParagonRx
  • William (Billy) Holden, PhD -- Chief Safety Officer – ParagonRx
  • Karen Lenoir, Client Services Director – ParagonRx

To register, click here.


To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email info@paragonrx.com