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The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.
Rockville, MD (Feb. 19)-The US Food and Drug Administration released a draft guidance for industry titled Influenza: Developing Drugs for Treatment and/or Prophylaxis. This document aims to assist companies in all phases of influenza drug development by addressing common questions the agency often receives regarding the potential for the emergency use of influenza drugs. FDA developed the draft in response to recent concerns regarding pandemic influenza and the ongoing public health risks of seasonal influenza.
The document covers preclinical development, early-phase clinical development, and Phase III protocol designs and endpoints specific to influenza A and influenza B drugs. The draft also discusses the role of animal studies as part of drug development, emphasizing that cell culture and animal-model studies can make valuable contributions to clinical-trial design. The document also describes considerations relating to the potential for emergency use of influenza drugs.
FDA will receive comments about the draft until May 21, 2009.