FDA issues request for public comment on clinical trial design
The FDA is accepting submissions until Thursday, Jan. 28.
The issuing of this document follows a public workshop that was hosted by the FDA, the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Disease (NIAID). It focused on investigational methods and their deployment for emerging diseases. This included a discussion of what was learned from the Ebola outbreak in West Africa.
This workshop also facilitated the evaluation of investigation methods' weaknesses and efficacy in certain areas and the determination of areas requiring further deliberation.
Submissions may be made via the online submission portal at the regulations.gov website or in paper form submitted by mail, courier or hand-delivered to the Division of Dockets Management at the FDA building on Fishers Lane in Rockville, Maryland.
Those submitting confidential information that should not be released publicly should utilize the paper form and indicate which parts are to be kept off public record.