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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance: , please submit online. Or submit written comments on the draft guidance before the deadline.

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All written comments should be identified with a docket number in this document. FDA-2022-D-1729

Reference number:
FDA-2022-D-1729
issued by:

Information issuing office

Pharmaceutical Evaluation Research Center

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. Pharmacological approaches to migraine treatment include drugs that stop migraine attacks when they occur (acute migraine treatment) and drugs that reduce the frequency of migraine attacks (prophylactic treatment). increase. Specifically, this guidance addresses the current thinking of the Food and Drug Administration (FDA) regarding overall development programs and clinical trial plans to support the approval of preventive treatments for migraine. This guidance does not address the development of drugs indicated for the acute treatment of migraine. Such developments are addressed in the Guidance for Industry, “Migraine: Acute Treatment Development” (February 2018).