The Food and Drug Administration is out with four new guidance documents touching on several aspects of the animal drug regulatory process including the use of data and other key aspects of the development process.
The finalized documents stem from draft guidance offered in July 2020, with “editorial changes” made to the final versions “to improve clarity,” FDA’s Center for Veterinary medicine noted. The new documents include guidance on the use of foreign data, use of “real-world” data and evidence, biomarkers and surrogate endpoints in studies to explore effectiveness, and adaptive and other designs for effectiveness studies.
The Animal Health Institute actively commented on the draft guidance and said it appreciated the finalized documents.
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“We hope CVM will demonstrate flexibility in implementing these guidances so that they work to allow the approval of new therapies to address unmet medical needs in animals,” the organization said in a statement to Agri-Pulse. “These provisions also hold the promise of allowing companies to reduce the number of animals in the research process.”
AHI also said it planned to work with CVM and Congress on “further improvements to the animal drug approval process” in the upcoming reauthorization of the Animal Drug User Fee Act.
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