Zdrowie i gospodarka · 26/06/2013

FDA Announces Draft Guidance for Expedited Drug Development Programs for Serious Conditions

The Food and Drug Administration (FDA) has released a draft guidance document outlining its policies and procedures for expedited drug development and review programs aimed at addressing unmet medical needs for serious or life-threatening conditions, including Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations.