# Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/clinical-trial-endpoints-for-the-approval-of-cancer-drugs-and-biologics-guidance-for-industry/2ab76b05-d847-445c-b212-0047a592f760

> FDA guidance document: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics:  Guidance for Industry. Issue date: December 19, 2018. Get complete insights and analysis.

---

## Details

- Title: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2018-12-19
- Last Changed: 2021-01-25
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2005-D-0225">FDA-2005-D-0225</a>

## Related Documents

- [Cancer Clinical Trial Eligibility Criteria: Brain Metastases](https://www.globalkeysolutions.net/guidances/guidance-document/cancer-clinical-trial-eligibility-criteria-brain-metastases/18dfb9e1-7a58-4743-8321-ecddace907a4)
- [E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population](https://www.globalkeysolutions.net/guidances/guidance-document/e11r1-addendum-clinical-investigation-of-medicinal-products-in-the-pediatric-population/e3307e6f-23c2-45a6-9825-5ae810b26dda)
- [Clinical Trial Imaging Endpoint Process Standards Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-trial-imaging-endpoint-process-standards-guidance-for-industry/910804b6-9e1d-47f8-8105-89b586c9622b)
