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...M pharm drug regulatory affairs i semester theory papers hrs week ii iii pharmaceutical jurisprudence forensic pharmacy iv laws related to product design safety environment practicals and development approval process regulation of clinical preclinical studies good manufacturing practices formulation production management comprehensive viva voce seminar on dissertation topic project work introductory final results marks lectures tutorials paper assignment total pertaining the research plan experimental discussion conclusion evaluation as per usa a detailed study federal food drugs cosmetics act restricted human biotechnological products with special emphasis history in b organization functions fda including historical developments c general definitions d adulterated misbranded e otc orphan orange book fast track f penalties applicable investigational new application inda nda bla anda snda supac bacpac post marketing surveillance text books guidebook for submissions by sandy weinberg cla...