Published in Vaccine Weekly, February 18th, 2004
The Fast Track designation means that FDA will take such actions that are appropriate to expedite the development and review of a license application for rPA102, when and if it is submitted to the FDA.
Under the FDA Modernization Act of 1997, the FDA's Fast Track Program is designed to expedite the development and review of a new drug that is intended for the treatment or prevention of a serious or life-threatening condition, and demonstrates the potential of a drug candidate to...
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