federal_register: 2021-21692
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-21692 | S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals". The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. The draft guidance is intended to offer an integrative approach that provides specific weight of evidence (WoE) criteria that inform whether or not a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply. | 2021-10-05 | 2021 | 10 | https://www.federalregister.gov/documents/2021/10/05/2021-21692/s1br1-addendum-to-s1b-testing-for-carcinogenicity-of-pharmaceuticals-international-council-for | https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21692.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals". The draft guidance was prepared under the auspices of... |