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FDA programs encourage and expedite drug development and approval

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Priority Review is intended for products that address unmet medical needs. Products generally must provide a significant improvement compared to marketed products for a particular disease. The benefit of the program is clear: The FDA has a six-month review goal for Priority Review applications after a complete application is filed, whereas a regular application has a 10- ......

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Source:wistechnology.com By Patricia Kaeding 12/14/05


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