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USA: FDA Confirms the Guidelines in the Development of ALS Drugs


The US Food and Drug Administration (FDA) has finalised guideline to assist sponsors in the clinical development of drugs and biological products for the treatment of amyotrophic lateral sclerosis (ALS).

This guidance focuses on specific clinical drug development and trial design issues that are unique to the study of ALS. The draft version was released in February 2018 and the final version incorporates a number of changes through the inclusion of a number of languages.

This tends to make the guidelines even more flexible for implementation in the manufacturing process. The main focus of the guidelines is in developing drugs on certain issues which are related exclusively to ALS. The document provides major recommendations which do not account as legally enforced norms.