FDA has unveiled its Action Plan for Rare Neurodegenerative Diseases, including amyotrophic lateral sclerosis (ALS).
The plan will involve the use of public-private partnerships and incorporate feedback from patients. The initiative will encompass regulatory science initiatives, changes to existing programs and new policy initiatives.
Milestones of the initiative include the creation of an FDA rare neurodegenerative diseases task force and public-private partnerships for rare neurodegenerative diseases in the fiscal year 2022. In addition, from fiscal years 2022 to 2026, the plan aims to develop disease-specific science strategies.
The initiative is an outgrowth of a Public Law 117-79, the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS) President Biden signed into law on December 23, 2021.
“We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” said…