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Re: None

Thursday, 02/05/2015 1:43:45 PM

Thursday, February 05, 2015 1:43:45 PM

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Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant - such as published literature or the agency's finding of safety and/or effectiveness of a previously approved drug product.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm

"This is our year!"

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