Published in Medical Letter on the CDC and FDA, November 20th, 2005
This designation may allow for the FDA to sanction company actions to expedite the development and review of a potential new drug application for Troxatyl to treat third-line AML. Fast track designation also provides the potential to seek accelerated approval in which the FDA may grant market approval based on a determination that the drug effect on a surrogate endpoint is reasonably likely to...
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