Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
December 19, 2018
January 25, 2021
2ab76b05-d847-445c-b212-0047a592f760
Related Documents
Cancer Clinical Trial Eligibility Criteria: Brain Metastases
Guidance DocumentJuly 10, 2020Center for Drug Evaluation and Research
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
Guidance DocumentApril 11, 2018Center for Drug Evaluation and Research
Clinical Trial Imaging Endpoint Process Standards Guidance for Industry
Guidance DocumentApril 27, 2018Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox