federal_register: 2024-27796
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-27796 | Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects." This draft guidance makes recommendations on followup testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. The guidance recommends a consistent process of followup testing and evaluation that first should be conducted for an Ames-positive active ingredient before proceeding with first-in-human (FIH) trials in healthy human subjects. These recommendations are intended to potentially help address and lower safety concerns before proceeding with FIH trials in healthy human subjects. | 2024-11-27 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/27/2024-27796/recommended-followup-testing-for-an-ames-positive-drug-active-ingredient-or-metabolite-to-support | https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-27796.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical... |