FDA Requests Comments on Draft Guidance for Reproductive Toxicity Testing

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FDA Requests Comments on Draft Guidance for Reproductive Toxicity Testing

The U.S. Food and Drug Administration (FDA) has requested comment on draft guidance ICH S5(R3), “Detection of Toxicity to Reproduction for Human Pharmaceuticals.” This document clarifies the qualification and potential use of alternative assays to assess reproductive risk and includes a list of compounds suggested for qualification of assays. FDA recognizes that this list is not complete and is requesting information on potential additional compounds to be added to the list.

The draft guidance ICH S5(R3) is available on the FDA website. An announcement in the November 13 Federal Register includes instructions on submitting comments on the draft guidance. To ensure consideration as the guidance is finalized, comments should be received by February 12, 2018.

Catherine Sprankle
Catherine Sprankle

Communications Specialist for NICEATM

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