Federal Register #2026-17927

FDA Guidance on Harmonized Reproduction Testing for Veterinary Drug Residues in Human Food

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final guidance for industry regarding reproduction testing for veterinary drug residues in human food. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are mentioned; this is a guidance announcement, not a procurement - Products/Services Requested: - No products, part numbers, or quantities are listed - Unique or Notable Requirements: - The guidance harmonizes international standards for reproduction testing of veterinary drug residues - Developed in collaboration with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - Aims to facilitate mutual acceptance of safety data for determining Acceptable Daily Intakes (ADIs) - Regulatory and industry representatives from multiple countries contributed - This is not a solicitation or award; it is an announcement of guidance availability - Comments on the guidance can be submitted via regulations.gov

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This guidance, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), aims to harmonize reproduction testing for evaluating effects from long-term, low-dose exposures to veterinary drug residues in food. The guidance facilitates mutual acceptance of safety data for determining Acceptable Daily Intakes (ADIs) for veterinary drug residues in human food. Comments on the guidance can be submitted via regulations.gov until the closing date.

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