Animal efficacy rule

The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical.^[1] The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism.^[2]

^ Snoy, PJ (September 2010). "Establishing efficacy of human products using animals: the US food and drug administration's 'animal rule'". Veterinary Pathology. 47 (5): 774–8. doi:10.1177/0300985810372506. PMID 20551476. S2CID 37206297.
^ Levine, GH; Handwerker, JL (2011). "Development of countermeasures for bioterrorism in the United States". In Gad, SC (ed.). Development of Therapeutic Agents Handbook. John Wiley & Sons. p. 231. ISBN 978-1-118-07711-5.

[Snoy-2010-1] Snoy, PJ (September 2010). "Establishing efficacy of human products using animals: the US food and drug administration's 'animal rule'". Veterinary Pathology. 47 (5): 774–8. doi:10.1177/0300985810372506. PMID 20551476. S2CID 37206297.

[Levine-2011-2] Levine, GH; Handwerker, JL (2011). "Development of countermeasures for bioterrorism in the United States". In Gad, SC (ed.). Development of Therapeutic Agents Handbook. John Wiley & Sons. p. 231. ISBN 978-1-118-07711-5.

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