Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers." This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- compliant toxicology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 This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2019-D-2330] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.” This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- ( printed page 37647) 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 This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review. DATES: Submit either electronic or written comments on the draft guidance by September 30, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations…
Other Federal Register documents from the same docket.
Citation: 84 FR 37646
