View the third webinar in spring series: http://bit.ly/apr-11-webinar, recorded on April 11.
In just about two weeks, the U.S. Food and Drug Administration (FDA) will host a two-day workshop on drug development for CFS and ME. The FDA’s review process is designed to test potential treatments for both safety and effectiveness for the condition they aim to treat. What does the phrase “safe and effective treatment” really mean?
We break down each word in that phrase to help participants understand how treatment candidates are reviewed and how patient experience in clinical trials affects the approval process.
Date/Time: April 11 at 1 p.m. EDT
Speakers: Kim McCleary, President & CEO, The Solve ME/CFS Initiative
Host: Suzanne Vernon, PhD, Scientific Director, The Solve ME/CFS Initiative
Here are links to resources related to this topic:
- The FDA’s Drug Review Process: Ensuring Drugs Are Safe & Effective (FDA materials)
- Enhancing Benefit-Risk Assessment in Regulatory Decision-Making (FDA materials)
- “Who Pays for Treatments and Cures?” (video from FasterCures’ Celebration of Science)
The first two programs in our spring webinar series provide helpful background information for this topic. Recordings are archived on the Association’s SolveCFS YouTube channel:
- “Overview of the Drug Development Landscape” (March 28, 2013, featuring Kristin Schneeman of FasterCures)
- “Finding Your Strongest Voice for Public Testimony” (April 4, 2013, featuring Leigh Reynolds and Kim McCleary of the Solve ME/CFS Initiative )
Thank you for your continued support of the Solve ME/CFS Initiative . You’re at the center of everything we do!