STP's Comments to FDA Guidance on Pathology Peer Review in Nonclinical Toxicology Studies

Dear Society of Toxicologic Pathology (STP) members,

As previously communicated, the STP Scientific and Regulatory Policy Committee (SRPC) formed a Working Group, which was charged with responding to the recently published FDA guidance “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers, Guidance for Industry”. This draft guidance originated from the FDA Office of Study Integrity and Surveillance (OSIS) and was published in the Federal Register August 01, 2019 for public comment.

Please find attached the finalized STP comments which have been endorsed by the SRPC and the EC and were submitted electronically to the FDA on September 16, 2019.

The FDA has set a deadline for comments on this draft guidance of September 30th, 2019. The FDA must consider all comments and questions it receives. Therefore, we encourage individual members or companies to read the FDA guidance and STP’s reply and submit their own comments directly to the FDA at this link.

If STP members have questions or comments, please reach out to the working group chairs, Bindu Bennet or Frank Geoly.

Sincerely,

The SRPC Working Group on Pathology Peer Review

Bindu Bennet & Frank Geoly (co-chairs), Karyn Colman, Jim Fikes, Sabine Francke, Natalie Keirstead, Barbara Munch (SQA), Karen Regan, Annette Romeike, Ken Schafer, Frederic Schorsch, Heath Thomas, Michael Thibodeau, John Vahle

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