Guidance for Industry on Cancer Drug and Biological Products-Clinical Data in Marketing Applications; Availability

Streszczenie

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.