federal_register: E8-29674
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-29674 | Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches." This draft guidance is intended to inform pharmaceutical manufacturers of the agency's thinking regarding genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products that are regulated by the Center for Drug Evaluation and Research (CDER), and to provide recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications. This draft guidance, when finalized, will clarify FDA's additional testing and exposure threshold recommendations for situations in which genotoxic or carcinogenic impurities are present. This draft guidance addresses synthetic impurities and degradants in drug substances, but does not otherwise address the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products. | 2008-12-16 | 2008 | 12 | https://www.federalregister.gov/documents/2008/12/16/E8-29674/draft-guidance-for-industry-on-genotoxic-and-carcinogenic-impurities-in-drug-substances-and-products | https://www.govinfo.gov/content/pkg/FR-2008-12-16/pdf/E8-29674.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches." This draft guidance is intended to inform... |