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Entreprise · 05/10/20011 min de lecture
Guidance for Industry on Cancer Drug and Biological Products-Clinical Data in Marketing Applications; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Cancer Drug and Biological Products--Clinical Data in Marketing Applications." This guidance provides recommendations for sponsors designing clinical trials to demonstrate the safety and efficacy of cancer treatments on the collection of data that can be submitted to support marketing claims in new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →