Postapproval Changes for Drugs: A Practical Guide (e-book)

E-books Member: $160.00 Nonmember: $225.00 Advanced therapies/cell and gene therapyApproval/marketing authorizationBiologics/ biosimilars/ vaccinesChemistry, Manufacturing and Controls (CMC)FoundationalGDUFAGlobalIntermediateMarket withdrawalPharmaceuticalsPharmacovigilance/postmarket surveillancePostmarketing requirement/postmarketing commitmentProduct LifecycleRisk management