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Home » Generic Drugmakers Call for U.S., EU To Align on Approvals, Inspections
Generic Drugmakers Call for U.S., EU To Align on Approvals, Inspections
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product.