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Home » FDA’s Final Guidance on Pre-Launch Drug Importation Largely Tracks Draft Policy
FDA’s Final Guidance on Pre-Launch Drug Importation Largely Tracks Draft Policy
The FDA has released final guidance for industry on the agency’s approach for overseeing requests for the importation of unapproved finished dosage form drugs by applicants preparing medicines for market launch of a pending new drug application (NDA), an abbreviated new drug application (ANDA) or biologics licensing applications (BLA) regulated by the agency’s Center for Drug Evaluation and Research (CDER).