GUIDANCE DOCUMENT
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients July 2020
- Docket Number:
- FDA-2019-D-0358
- Issued by:
-
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
[Draft published 3/13/2019]
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 CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents) when appropriate. This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials.
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All written comments should be identified with this document's docket number: FDA-2019-D-0358.