Hopes and concerns regarding the implementation of expanded access protocols in amyotrophic lateral sclerosis
- PMID: 36999228
- DOI: 10.1002/mus.27828
Hopes and concerns regarding the implementation of expanded access protocols in amyotrophic lateral sclerosis
Keywords: EAP; amyotrophic lateral sclerosis; compassionate use; expanded access; expanded access protocol.
Comment on
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Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS).Muscle Nerve. 2023 Jun;67(6):456-463. doi: 10.1002/mus.27819. Epub 2023 Apr 5. Muscle Nerve. 2023. PMID: 36929648
References
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- Paganoni S, Macklin EA, Hendrix S, et al. Trial of sodium Phenylbutyrate-Taurursodiol for amyotrophic lateral sclerosis. N Engl J Med. 2020;383(10):919-930.
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- Yerton M, Winter A, Gelevski D, et al. Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS). Muscle Nerve. 2023;67(6):456-463. doi:10.1002/mus.27819.
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- FDA Releases Action Plan for Rare Neurodegenerative Diseases Including ALS, U.S. FOOD & DRUG ADMINSTRATION website, https://www.fda.gov/news-events/press-announcements/fda-releases-action-..., updated June 23, 2022. Accessed March 28, 2023.
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