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FDA Regulatory-Rulemaking from Real-World Data from Registries

Published: December 11, 2021

Food and Drug Administration draft guidance outlining recommendations for using real-world data from registries to support regulatory decision-making. Pharmaceutical manufacturers and other life-sciences industry stakeholders should review guidance & submit comments by February 28, 2022

Source: natlawreview.com

Related Topics:

Product Development To Support LabelingDrug AdministrationReal World DataAssessing RegistriesSupport Regulatory Decision MakingBiological Products GuidanceDraft GuidanceCentury Cures ActCures ActFederal FoodCosmetic ActRegulatory DecisionPatient Reported Outcome MeasuresMedical Product DevelopmentSupport LabelingLinking RegistriesReal World DataUrating Data In RegistriesPharmaceutical ManufacturersIve Sciences Industry