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An Overview of the Legislative Framework for FDA Expedited Programs for Serious Conditions

On June 26, 2013, the US Food and Drug Administration (FDA) announced in the Federal Register, the publication of a draft guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics.” This draft guidance represents an expanded effort from the FDA to facilitate and expedite development and review of new drugs to address unmet medical need for serious conditions. Alejandra Muntañola of Thomson Reuters gives an overview of FDA’s legislative framework.….pdf