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Jump-Start 2023 With 2022 s Must-Know FDA Guidances On Pharmaceutical Production

The FDA published a number of draft and final guidance documents in 2022. In this e-book, we summarize the most important guidance documents related.

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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

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 | Wiley Rein LLP

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 statesGuidance the agencyNational drug codeDrug administrationOffice of regulatory affairsLaunch activities importation requestsFinal guidanceDrug evaluationNew drugsRegulatory affairsImport divisionDraft guidance

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