Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine. Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.
According to the FDA, “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.” A drug (or vaccine) that receives Fast Track designation is eligible for Accelerated Approval and Priority Review,which can considerably speed the time to market.
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