ALS Drug Development Guidance Available for Comment

Make Your Voice Heard
We are happy to announce that the first draft of the community-driven FDA Guidance on ALS drug development is available for your review and comment. In our April e-newsletter, we shared the exciting news that the Collaboration for a Cure (a consortium of leading organizations in the ALS community, including the Les Turner ALS Foundation) had created a new pathway for ALS drug development to improve and speed up the FDA approval process.

The goal of the ALS Guidance is to serve as a roadmap for the pharmaceutical industry to navigate the regulatory development process and to provide the FDA with an ALS community-focused view of the disease and how it should approach potential therapies for ALS.

As a member of the ALS community, this is an important opportunity for your voice to be heard. We encourage you to take the time to review the draft and submit your feedback to help change the future of ALS. Feel free to include comments expressing support or concerns as well as suggestions for how the ALS Guidance might be improved, all of which will be taken in to account in creating the next draft for submission to the FDA.

On behalf of the Collaboration for a Cure, the ALS Association has created a wonderful guide to help you through the steps of downloading the draft, reviewing it and submitting your comments. You can find the helpful guide here.

To download the guide immediately, click here. The deadline for submitting comments is May 30, 2016.Submit your comments or questions to:
FDAALSGuidance@alsa-national.org

Click here to learn more about the Collaboration for a Cure and a question and answer document about the FDA drug approval process. Learn how you can make your voice heard on this important issue!