federal_register: 2016-19875

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
2016-19875 Good Laboratory Practice for Nonclinical Laboratory Studies Proposed Rule The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity. 2016-08-24 2016 8 https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/2016-19875.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and...

Links from other tables