Zdrowie i gospodarka · 05/07/2005

Draft Guidance; Emergency Use Authorization of Medical Products; Availability

The Food and Drug Administration (FDA) is announcing the availability of draft guidance entitled "Emergency Use Authorization of Medical Products." The draft guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. The draft guidance is not final and is not in effect at this time. FDA also is announcing an opportunity for public comment on the proposed collection of information related to emergency use authorizations by the agency.