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CDER Issues MAPP on Parenteral Drugs in Plastic Immediate Containers
Drugs Regulatory Affairs
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning new drug applications for parenteral drugs that will be packaged in plastic immediate containers.
Container applications that require animal studies more complex than confirmatory or USP testing must be submitted as an NDA, according to the agency.
The MAPP applies to small- and large-volume parenteral products, and applies to products in plastic immediate containers regardless of whether the plastic was previously used for an approved product.