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FDA: Draft Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics

27.06.2013
The provisions of this guidance, when finalized, will replace the current guidance for industry entitled Fast Track Drug Development Programs Designation, Development, and Application Review issued January 2006. The provisions of this guidance relating to available therapy, when finalized, will replace the current guidance for industry entitled Available Therapy (issued 26 July 2004).

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