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Negócios · 05/10/20011 min de leitura
Guidance for Industry on Cancer Drug and Biological Products-Clinical Data in Marketing Applications; Availability
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →