Community Effort Underway to Develop ALS Drug Development Guidance

A collaborative effort of patients, healthcare professionals, scientists, and industry experts is underway to develop an ALS drug development guidance document to help accelerate therapy development for the disease. The goal of the document is to provide the biopharmaceutical industry with guidelines for the regulatory process in ALS drug development, as well as to provide community input to the FDA on how to approach the regulatory pathway for ALS therapies. The initiative was inspired by the groundbreaking efforts of the Parent Project Muscular Dystrophy, who developed an FDA guidance document for Duchenne muscular dystrophy (see Oct 2014 news), and is being shaped at all stages by input from ALS patients and their families. The guidance document will be made available to the public for feedback in early 2016, and subsequently submitted to the US FDA for approval. Representatives from Prize4Life are also participating in the initiative!

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disease-als topic-biomarkers topic-clinical topic-randd
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