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The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
Developmental Testing Of IV Solutions
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.