Published in Food and Drug Law Weekly, November 3rd, 2006
Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and address unmet medical needs.
Agennix submitted applications to the FDA for Fast Track designation based on positive randomized, placebo-controlled phase II results with oral TLF solution in NSCLC and with topical TLF gel in diabetic foot ulcers.
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