Cancer Clinical Trial Eligibility Criteria: Performance Status; Draft Guidance for Industry, Institutional Review Boards, Clinical Investigators; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the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 Specifically, this draft guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status.
Abstract as published in the Federal Register.
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