FDA Sets Up Expedited Review Pathway For Certain Breakthrough Drugs

March 13, 2015 at 1:57 PM
FDA codified an expedited review pathway for breakthrough-designated drugs in a manual of policies and procedures (MAPP) released this week, instructing FDA review teams to act at least one month before the Prescription Drug User Fee Act (PDUFA) goal date for these applications. FDA confirmed it had been informally putting drugs through expedited review for several months, according to an industry attorney. In order for a breakthrough drug to be considered for an expedited review, it must have these qualifications:...

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