Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Brain Metastases." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.