Zdrowie i gospodarka · 22/10/2014

Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Migraine: Developing Drugs for Acute Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.