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USA: FDA Draft and Final Guidance’s Detail Development of New Drugs for Neurological Disorders

Friday, February 16, 2018: The US Food and Drug Administration (FDA) released seven draft, revised draft and final guidance documents on everything from how to develop new drugs to treat early Alzheimer’s, Duchenne Muscular Dystrophy and acute migraines to guidance on how to prepare a pre-request for designation for a combination product.

FDA Commissioner noted the five guidance’s issued to address neurological disorders "benefited from the streamlined approach" of a pilot project testing "a new, streamlined process for writing science-based, practical guidance documents and getting them out more quickly."

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