ALS Drugs: FDA May Adjust Development Recommendations In Real Time For Ongoing Programs

26 Aug 2022

Agency’s action plan for rare neurodegenerative diseases maps out over five years, but knowledge gained can inform products currently in development; new FDA grant program looks to invest in remote use of clinical outcome assessments for amyotrophic lateral sclerosis.

Real time — Lessons learned from activities under FDA's ALS Science Strategy may be applied in real time to ongoing development programs. • Source: Shutterstock

Learnings from early activities under the US Food and Drug Administration’s five-year ALS Science Strategy could be leveraged and applied to therapeutics currently in development, Office of Neuroscience Director Billy Dunn said.

During a 24 August stakeholder webinar on the Accelerating Access to Critical Therapies for ALS Act, Dunn said that even...