federal_register: 2024-28033
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-28033 | Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development." This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting. This guidance finalizes the draft guidance entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development" issued on May 2, 2022. | 2024-11-29 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/29/2024-28033/use-of-circulating-tumor-deoxyribonucleic-acid-for-curative-intent-solid-tumor-drug-development | https://www.govinfo.gov/content/pkg/FR-2024-11-29/pdf/2024-28033.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 final guidance for industry entitled "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development." This guidance is intended to help sponsors... |