Why Are Written Comments Important? How Are They Utilized?
Written comments are compiled and shared with the FDA Advisory Committee members prior to the date of a product’s/ company’s Advisory Committee meeting. Thus, written comments are a critical part of helping to provide context to the Advisory Committee.
Who Should Consider Submitting Written Comments?
Any member of the public with a vested interest in the product’s review, and /or experience and expertise in the disorder that the therapeutic product has been designed to benefit.
Can non US resident submit testimony?
What types of information should be included in written testimony?
The written testimony you submit should reflect your direct experiences with Duchenne and the product under review. The Advisory Committee will be presented with a vast amount of data about the experimental product and is being asked to determine whether enough safety and efficacy data has been made available to warrant access to the public. Testimony from those who have been involved in the clinical trials as a participant, parent of a participant, clinician, researcher, or community member and have first-hand knowledge of how this product has impacted the daily life of individuals living with Duchenne are critical. Testimony from community members who are awaiting access to these therapies is also very important.
Points for consideration:
For those with experience on the product:
For those outside of the trial/experience with product some things to think about for your submission:
Describe how Duchenne impacts your son, you, and your family
Describe what function your son wishes he could maintain and worries about losing over time
Describe what meaningful benefit of a drug would be to your son and your family
Deadlines & Instructions
For the Eteplirsen AdComm
Written testimonies should be submitted on or before April 11th
Send your email to: PCNS@fda.hhs.gov
Email subject line: Written testimony submission for FDA Advisory Committee Meeting to consider Eteplirsen
Attn: Moon Hee V. Choi
Please be sure to indicate "The following is my written testimony submission for the FDA Advisory Committee Meeting to consider Eteplirsen - April 25, 2016"
Let me know if I can help in any way. Consider copying email@example.com, we’d like to compile all them.