Follow-up Letter to the FDA
We delivered a letter to the FDA on Friday, June 4. In our letter, we requested that the agency:
- Issue a clear statement about its willingness to apply the flexibility described within the 2019 Guidance document.
- Commit to providing the ALS community with a detailed report about how it has been implementing the Guidance since it was issued.
As we made clear to the FDA, we simply cannot accept a world where people with ALS have to continually go before the agency to make our case again and again.
Perspectives from People Living with ALS
View more than 150 responses to a questionnaire that was opened to the ALS community in advance of the May 25, 2021 We Can’t Wait Action meeting with the FDA and industry officials. These perspectives provide a clear picture of the urgency action the community is seeking to accelerate access to potentially beneficial therapies.
Read more here about our urgent calls to action to FDA and the pharmaceutical industry.
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