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Fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical to the enclosed labeling text for the package insert. Pdf and PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012. Page 3 REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act PREA 21 U.S.C. The December 19 2014 submission constituted a complete response to our September 26 2014 action letter. 80 and 314. 81. If you have any...
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