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DOI: 10.1080/01926230701322135
A Regulatory Forum for Toxicologic PathologyEditor, Regulatory Forum Pfizer Inc Toxicologic Pathology is the premiere journal for discussion of topical and controversial issues in regulatory toxicologic pathology. To better address the regulatory aspects of toxicologic pathology, we are initiating a Regulatory Forum section as a regular feature of Toxicologic Pathology. The Regulatory Forum will include Society of Toxicologic Pathology (STP) position papers, other articles on best practices and regulatory strategy, comments on draft and final regulatory guidance, opinion papers by individuals from government, industry or academia, short commentaries or letters by individuals or groups, and informal advertisements for regulatory "flavored" events. One goal of the Forum is to stimulate and share discussion of controversial subjects. This first issue of "The Regulatory Forum" contains the STP’s recommendations for the use of pathology images in compliance with the Code of Federal Regulations (CFR), Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures). We would be interested in your perspective regarding this important issue. Subsequent columns will include STP’s recommendation on organ weight and STP’s response to the EMEA’s Draft Guideline on Detection of Early Signals of Drug induced Hepatotoxity in Non Clinical Studies. We expect the Regulatory Forum to become a regular feature of Toxicologic Pathology. A new committee of STP members will be responsible for driving this concept. We seek 5–6 volunteers representing industry (pharmaceutical and/or chemical), academia, and government (Regulatory Agencies, NTP, NIEHS, etc.) to form this committee. The future of the Regulatory Forum will be driven by you, the membership. Let us know what you want to see and give strong consideration to becoming an active member on the committee. Please comment on this column’s topic, suggest future Regulatory Forum content, or volunteer by sending a message toroy.1.kerlin{at}pfizer.com. Sincerely,
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