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DR Ryan

11/13/13 8:41 PM

#77225 RE: dr_lowenstein #77224

From FDA website:

Fast Track

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.



http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

So you think ELI 216 qualifies? I sure think it does and with how the FDA is pushing abuse deterrent opioids, I think it's a lock.
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Couch

11/13/13 8:47 PM

#77226 RE: dr_lowenstein #77224

No it does more than that. The FDA Fast Track Development Program is a designation that accelerates the approval of investigational new drugs undergoing clinical trials.