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In Case You Missed It: Takeaways From Final Guidance For Submitting Pre-Launch Activities Importation (PLAIR) Requests To FDA For Drug Products Prior To Anticipated Approval - Food and Drugs Law

The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled "Pre-Launch Activities Importation Requests (PLAIR)" (Final Guidance).

United statesTrevor lasalviaRegulatory affairsNational drug codeDrug administrationLaunch activities importation requestsFinal guidanceDrug evaluationNew drugsImport divisionDraft guidanceProject assistantIn case you missed it takeaways from final guidance for submitting pre launch activities importation plair requests to fda drug products prior anticipated approvalLife sciencesFood and drugs law

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