FDA Sets Up Expedited Review Pathway For Certain Breakthrough Drugs

FDA Sets Up Expedited Review Pathway For Certain Breakthrough Drugs-insidehealthpolicy: 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.