News Briefs: FDA accepts animal data for some drug approvals
The Food and Drug Administration (FDA) has amended its new drug and biological product regulations so that certain human drugs and biologics may be approved for marketing based on evidence of effectiveness from appropriate animal studies.
This new rule will apply when adequate and well-controlled clinical studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. The drugs or biologics must be intended to reduce or prevent serious or life-threatening conditions.
Under this new rule, certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances may be approved for use in humans based on evidence of effectiveness derived only from appropriate animal studies and any additional supporting data. Products evaluated for effectiveness under this rule will be evaluated for safety under pre-existing requirements for establishing the safety of new drug and biological products.
FDA proposed this new regulation Oct. 5, 1999. The final rule went on display May 30, 2002, and was published in the Federal Register Friday, May 31. The rule took effect June 30.
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