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Tell Us Why You Think Ataxia Deserves Regulatory Flexibility

Thank you for submitting your comments for the FDA!

NAF gathered feedback from the Ataxia community to submit to the FDA. We’re concerned with the FDA’s decision to refuse to file Biohaven’s new drug application (NDA) for troriluzole without a full review of the clinical trial results. Read our full statement here. 
It is well-established in FDA regulation and policy that rare diseases face unique challenges in drug development and that these challenges demand a more flexible approach. Our statement lays out the reasoning behind our concern and demonstrates why Ataxia is a rare disease that warrants additional flexibility. Now is the time to share the voice of the Ataxia community! The FDA needs to know your perspective and what is important to YOU in drug development. We collected comments from:
 
  • People affected by ALL types of Ataxia or rare neurodegenerative diseases
  • Family members, friends, and/or caregivers of people affected
  • Clinicians and researchers
  • Other healthcare providers
  • Nonprofit or other advocacy organizations and their employees
 
The feedback we collected will be included in our outreach to the FDA. We will share the package of information with the community after it has been submitted.


Thanks again for your support!

 

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