federal_register: 2022-09459
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-09459 | Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development." This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials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 setting. | 2022-05-03 | 2022 | 5 | https://www.federalregister.gov/documents/2022/05/03/2022-09459/use-of-circulating-tumor-deoxyribonucleic-acid-for-early-stage-solid-tumor-drug-development-draft | https://www.govinfo.gov/content/pkg/FR-2022-05-03/pdf/2022-09459.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development." This draft guidance is intended to help sponsors... |