FDA Conducts first-ever public hearing related to ALS


In February 2013, the U.S. Food and Drug Administration (FDA) conducted its first-ever public hearing specific to ALS. Patients, caregivers, physicians and researchers addressed a panel of representatives from the FDA. The ALS Association and MDA partnered together to represent the ALS community at large and urged the FDA to partner with the community to help expedite the drug development and approval process and bring new treatments to patients as soon as possible. A variety of topics were discussed including: how people with ALS view benefit and risk; innovation and flexibility on clinical trial design; FDA engagement with investigators and industry leaders early and more frequent during the development process; the speed of the regulatory process; and FDA engagement with patients, organizations, including during the review process.

Learn more about successful past ALS advocacy efforts by viewing this timeline.