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GUIDANCE DOCUMENT

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry Guidance for Industry September 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-N-0035
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2013-N-0035.

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