The ALS Association and MDA Urge FDA to Help Speed ALS Drug Development
Yesterday, The ALS Association and the Muscular Dystrophy Association (MDA) submitted joint comments to the U.S. Food and Drug Administration (FDA) thanking the agency for holding the first ever ALS-specific public hearing on February 25, 2013 and urging them to take action to help expedite the development and approval of new treatments for ALS.
The FDA convened last month’s public hearing at the request of The ALS Association and MDA. The hearing was attended by nearly 200 people from across the country representing every segment of the ALS community, including people with ALS, caregivers, physicians, ALS researchers, industry representatives and nearly every major ALS organization in the United States. A webcast of the hearing is available here: http://tinyurl.com/azsnrb6. The comments submitted by The Association and MDA follow-up on the hearing and request the agency respond to several key action items including:
- Develop a plan of action that includes regular communications between the ALS community and the FDA;
- Identify new ways to design ALS clinical trials;
- Establish a benefit-risk framework that recognizes the willingness of people with ALS to accept greater risk in order to access potential treatments; and
- Utilize biomarkers to help speed clinical trials.
The ALS Association is proud to partner with the MDA on these critical issues as both organizations work to find new treatments for ALS as soon as possible. The Association also thanks the hundreds of people with ALS and family members who have submitted comments to the FDA and who participated in the February 25 hearing.
For more information: