The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs to support approval of prescription drugs for the acute treatment of migraine.3 This guidance does not apply to overthe-counter drug products. This guidance also does not address the development of drugs indicated to reduce the frequency of migraine attacks. Such development will be addressed separately in a future guidance.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.