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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers." When final, this guidance will represent FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies using non-human specimens. When whole slide images are used as part of a nonclinical study conducted in compliance with the GLP regulations, adequate documentation is critical. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations.
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-2021-D-1268] 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 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers.” When final, this guidance will represent FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies using non-human specimens. When whole slide images are used as part of a nonclinical study conducted in compliance with the GLP regulations, adequate documentation is critical. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations. DATES: Submit either electronic or written comments on the draft guidance by June 7, 2022 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 Subm…
Other Federal Register documents from the same docket.
Citation: 87 FR 20872
