federal_register: 2020-27288
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27288 | Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction | Notice | The Food and Drug Administration (FDA) is correcting a notice entitled "Qualification Process for Drug Development Tools; Guidance for Industry; Availability" that appeared in the Federal Register of November 25, 2020. The document announced the availability of a final guidance for industry and FDA staff that met the 21st Century Cures Act's requirement to issue guidance on this qualification process and elaborated on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other drug development tools. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error. | 2020-12-11 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/11/2020-27288/qualification-process-for-drug-development-tools-guidance-for-industry-availability-correction | https://www.govinfo.gov/content/pkg/FR-2020-12-11/pdf/2020-27288.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is correcting a notice entitled "Qualification Process for Drug Development Tools; Guidance for Industry; Availability" that appeared in the Federal Register of November 25, 2020. The document announced the... |