Guidance for Industry Expedited Programs for Serious Conditions––Drugs and Biologics

Posted by Lainie Shapiro:  FDA recently published draft guidance for industry on developing new drugs and biologics and expedited approval systems.  The document is here:

The following four FDA programs are intended to facilitate and expedite development and 15 review of new drugs to address unmet medical need in the treatment of a serious or life- threatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation (see the FDA Guidance for an overview of the programs).


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