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Home » FDA Cuts Wait for Certain ANDA Approvals, Clears Up Misunderstandings on Reference Drugs
FDA Cuts Wait for Certain ANDA Approvals, Clears Up Misunderstandings on Reference Drugs
To help speed the approval of generics, the FDA Friday said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness.