Exam (elaborations)
RAC- chapter 3 Questions and Answers
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- Institution
Decision Tree - Answer-1.Drug,Device or Some Combination - For human use -drug - new drug = New NDA Route 505(b)(1) 2.Drug,Device or Some Combination- For human use -drug- NOT new drug- same formulation as RLD=ANDA Route 3. Drug,Device or Some Combination- For human use -drug- not new drug- NOT...
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