Zdrowie i gospodarka · 20/02/2009
Draft Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Influenza: Developing Drugs for Treatment and/or Prophylaxis." Recent concerns about the possibility of pandemic spread of novel influenza strains have increased interest in influenza drug development for both seasonal and pandemic settings. The purpose of this guidance is to assist sponsors in all phases of influenza drug development and to address questions FDA often receives regarding the potential for emergency use of influenza drugs for the treatment and/or prophylaxis of influenza.