{"database": "openregs", "table": "federal_register", "rows": [["2019-16361", "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.\" This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- compliant toxicology studies. When pathology peer review occurs as part of a nonclinical laboratory study conducted in compliance with GLP regulations, it should be well-documented. However, documentation practices during pathology peer review have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review.", "2019-08-01", 2019, 8, "https://www.federalregister.gov/documents/2019/08/01/2019-16361/pathology-peer-review-in-nonclinical-toxicology-studies-questions-and-answers-draft-guidance-for", "https://www.govinfo.gov/content/pkg/FR-2019-08-01/pdf/2019-16361.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.\" This draft guidance represents FDA's current...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2019-16361"], "units": {}, "query_ms": 0.4488760605454445, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}