The Food and Drug Administration (FDA) issued a draft guidance on Friday morning to cut unnecessary animal testing for cancer drugs.
The FDA said the guidance, titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products," will give recommendations for general toxicology studies.
The guidance will also give recommendations on when animal testing may be unnecessary because there is no binding or pharmacological activity, per the FDA.
“This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of animal testing during drug development,” said the FDA’s Oncology Center of Excellence Director Dr. Angelo de Claro.
The FDA asks that public comments on the draft be submitted by July 30 for review before the guidance is finalized.
Read the full draft here.
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