federal_register: 2019-26994
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-26994 | Qualification Process for Drug Development Tools; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a draft guidance for industry and FDA staff entitled "Qualification Process for Drug Development Tools." Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act's mandate to issue guidance on this qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs, and the draft guidance of the same name issued January 7, 2014, is withdrawn. | 2019-12-16 | 2019 | 12 | https://www.federalregister.gov/documents/2019/12/16/2019-26994/qualification-process-for-drug-development-tools-draft-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2019-12-16/pdf/2019-26994.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a draft guidance for industry and FDA staff entitled... |