federal_register: 2010-26927

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

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-26927 Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Qualification Process for Drug Development Tools." This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. The draft guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that the evaluation is comprehensive and reliable. 2010-10-25 2010 10 https://www.federalregister.gov/documents/2010/10/25/2010-26927/draft-guidance-for-industry-on-qualification-process-for-drug-development-tools-availability https://www.govinfo.gov/content/pkg/FR-2010-10-25/pdf/2010-26927.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Qualification Process for Drug Development Tools." This draft guidance describes the qualification process for drug development tools...

Links from other tables