federal_register: 2019-16361
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-16361 | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers." This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- compliant toxicology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 This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers." This draft guidance represents FDA's current... |