FDA unveiled its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) on June 23, 2022. The plan is a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases through advancing the development of, and improving patient access to, safer and more effective medical treatments and products.
The action plan outlines how FDA will move forward in addressing challenges in drug development for rare neurodegenerative diseases. FDA will take actions such as regulatory science initiatives, enhancements to existing programs, and new policy initiatives. The plan was developed in accordance with the Accelerating Access to Critical Therapies for ALS Act, which was signed into law on December 23, 2021.
