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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. REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act PREA 21 U.S.C. 80 and 314. 81. If you have any questions call Maureen Dillon-Parker Chief Project Management Staff at 301 796-0706. DEPARTMENT OF HEALTH AND HUMAN...
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