federal_register: 2020-26051

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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
2020-26051 Qualification Process for Drug Development Tools; Guidance for Industry; Availability Notice The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a final 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 requirement to issue guidance on this qualification process. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs. This guidance finalizes the draft guidance of the same title issued on December 16, 2019. 2020-11-25 2020 11 https://www.federalregister.gov/documents/2020/11/25/2020-26051/qualification-process-for-drug-development-tools-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2020-11-25/pdf/2020-26051.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a final guidance for industry and FDA staff entitled...

Links from other tables