# S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/s1br1-addendum-to-s1b-testing-for-carcinogenicity-of-pharmaceuticals-guidance-for-industry/1d41223b-0838-4b9d-ad50-e8e6371d700e

> FDA guidance document: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals:  Guidance for Industry. Issue date: November 02, 2022. Get complete insights and analysis.

---

## Details

- Title: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-11-02
- Last Changed: 2022-11-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0669">FDA-2021-D-0669</a>

## Related Documents

- [E8(R1) General Considerations for Clinical Studies](https://www.globalkeysolutions.net/guidances/guidance-document/e8r1-general-considerations-for-clinical-studies/c5e52286-b058-4b0f-b1f2-e589be1aaf84)
- [M10 Bioanalytical Method Validation and Study Sample Analysis](https://www.globalkeysolutions.net/guidances/guidance-document/m10-bioanalytical-method-validation-and-study-sample-analysis/ae7fec2e-4331-4dbe-a88a-8bb7bbd7e464)
- [Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/qualification-process-for-drug-development-tools-guidance-for-industry-and-fda-staff/f5a3f8af-54f6-44ba-9eea-d3cc587444f7)