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GUIDANCE DOCUMENT

Migraine: Developing Drugs for Acute Treatment February 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-1540
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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All written comments should be identified with this document's docket number: FDA-2014-D-1540.

 
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