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# Migraine Drug Development Guidance
- URL: https://www.fdaweb.com/migraine-drug-development-guidance/
- Published: 2023-06-01T12:00:00.000Z
- Updated: 2026-09-14T18:35:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154589

FDA has published a draft guidance, *Migraine: Developing Drugs for Preventive Treatment*, to assist sponsors in the clinical development of these drugs. Specifically, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/migraine-developing-drugs-preventive-treatment?ref=fdaweb.com) addresses FDA’s current thinking about the overall development program and clinical trial designs to support the approval of drugs for the preventive treatment of migraine. It does not address the development of drugs indicated for the acute treatment of migraine, which is addressed in a 2018 guidance.

The guidance does not contain a discussion of the general issues of statistical analysis or clinical trial design.