2023-11751: Migraine: Developing Drugs for Preventive Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Migraine: Developing Drugs for Preventive Treatment." This draft guidance document is intended to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. The draft guidance is intended to complement, not replace, the guidance for industry "Migraine: Developing Drugs for Acute Treatment," and focuses on specific drug development and trial design issues that are unique to the study of drugs for the preventive treatment of migraine. This draft guidance is intended to serve as a focus for continued discussions among FDA's Division of Neurology II, sponsors, the academic community, and the public.
The agency’s own summary, as published.
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