Comment from ALS Association
AnonymousSupportAdvocacy
Summary: The ALS Association supports the Haystack Project's request for the FDA to modernize the regulatory framework for rare, serious diseases like ALS. They argue that the current regulatory process is too slow for patients with fatal diseases and advocate for disease-specific factors and fit-for-purpose designs to expedite the development of safe and effective therapies.
The ALS Association writes in strong support of efforts to modernize the regulatory framework governing the development and evaluation of therapies for rare, serious diseases, including amyotrophic lateral sclerosis (ALS). We support the Haystack Project and other patient advocacy groups’ request for the FDA Commissioner to begin rulemaking to amend 21 CFR § 314.126(b) and 21 CFR §312.47.