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- W3196170147 abstract "INTRODUCTIONEmployment of∗ current good manufacturing practice (CGMP) and approval of anew drug application (NDA) are two pillars of federal law providing support ofmanufacturing quality for pharmaceutical drug products offered to American consumers in the U.S. marketplace. These requirements are established in the FederalFood, Drug and Cosmetic Act (FDCA). In this chapter, we will discuss these tworequirements and how they interfacewith each other in the FDAprograms designedto execute the mandates of the law." @default.
- W3196170147 created "2021-08-30" @default.
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- W3196170147 date "2008-12-02" @default.
- W3196170147 modified "2023-09-24" @default.
- W3196170147 title "Current Good Manufacturing Practice and the Drug Approval Process" @default.
- W3196170147 doi "https://doi.org/10.3109/9781420070439-20" @default.
- W3196170147 hasPublicationYear "2008" @default.
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