Regulatory Update: Pending and New Guidance

| 01 March 2009

This draft guidance provides information on the development of animal efficacy models under the "Animal Rule" (21 CFR 314.600 for drugs; 21 CFR 601.90 for biologics). The Animal Rule is the means by which FDA marketing approval may be granted based on animal efficacy data when human efficacy testing is neither ethical nor feasible.


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