FDA Allows Flexible Trials In Urgent Bid For 'Game Changer' Ebola Vaccine

FDA is offering industry sponsors wide flexibility in its quest for speedy development of an Ebola vaccine and treatments: The agency is working with developers to review data for candidate treatments in "real time," encouraging simple trials designs that would allow studies to begin soon in Africa, allowing companies to conduct parts of the study process "in parallel," and holding out orphan drug designation as an incentive. A top agency official said last week that approval of an Ebola vaccine...