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Structured Approach to Benefit-Risk Assessment:Draft PDUFA V Implementation Plan
GOOD MANUFACTURING PRACTICE (cGMP)
REGULATORY TRENDS AND QA
DURGA_PRASAD
March 23, 2013, 9:11pm
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http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf