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.
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The FDA animalefficacyrule (also known as animalrule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening...
which have only been tested or approved under the animalefficacyrule are loosely known as animal products. Under certain conditions, an EUA may authorize...
dual indications under the U.S. Food & Drug Administration’s (FDA) animalefficacyrule as a pivotal-stage radiation countermeasure, and under the FDA’s...
Administration (FDA) has established the "animalefficacyrule" allowing licensure to be approved on the basis of animal model studies that replicate human disease...
anti-radiation pharmaceutical, under the U.S. Food and Drug Administration's animalefficacyrule, without human testing, and as an oncological, following the approval...
the efficacy of anthrax immune globulin in humans, it was tested in rabbits and monkeys under the FDA's animalefficacyrule. Following efficacy testing...
abstaining from the use of animal products—particularly in diet—and an associated philosophy that rejects the commodity status of animals. A person who practices...
Administration (FDA) has established the "animalefficacyrule" allowing limited licensure to be approved on the basis of animal model studies that replicate human...
cases (10 male, 8 female) treated by Mesmer. In stressing the efficacy of Mesmer's "animal magnetism" interventions, d'Eslon defended (at p. 124) the absence...
is converted into visible light; the rest is lost as heat. The luminous efficacy of a typical incandescent bulb for 120 V operation is 16 lumens per watt...
effects among autistic people across the age spectrum. A 1995 study on the efficacy of Grandin's device, conducted by the Center for the Study of Autism, working...
bioluminescent bacteria, and terrestrial arthropods such as fireflies. In some animals, the light is bacteriogenic, produced by symbiotic bacteria such as those...
Dosage Form New Animal Drugs; Change of Sponsor". Federal Register. 20 May 2014. "Oral Dosage Form New Animal Drugs; Change of Sponsor". A Rule by the Food...
cell culture) and in vivo (animal model) experiments using wide-ranging doses of the study agent to obtain preliminary efficacy, toxicity and pharmacokinetic...
in vitro testing strategies that limit animal use while supplying key information for product safety and efficacy decisions. NORINA is a database containing...
basis of clinical trial evidence for its best-available combination of efficacy, safety, and tolerability or (2) chosen based on the clinical experience...
cases, and the programs that are readily available are questionable in efficacy. Research into feline vaccines for toxoplasmosis is ongoing, with several...
popular.[citation needed] There is not good clinical evidence supporting the efficacy of Gua sha. In use, it nearly always damages the skin. Negative side effects...
with experimental testing and confirmation of the compound based on animalefficacy models and ADMET (in vitro and in situ) tools that may be followed...
to an overabundant species and other animals in the ecosystem competing for food, space, and resources. The animals in an overpopulated area may then be...
brincidofovir under the agency's AnimalRule, which allows findings from adequate and well-controlled animalefficacy studies to serve as the basis of...
Act due to the results of the Drug Efficacy Study Implementation (DESI) program (which indicated a lack of efficacy). The new formulation simply replaced...
Mary Temple Grandin (born August 29, 1947) is an American academic and animal behaviorist. She is a prominent proponent of the humane treatment of livestock...
consumers felt ripped off when informed of the lack of evidence for the efficacy of homeopathic remedies, such as those sold by Walmart and CVS. In 2021...
Retrieved September 6, 2016. Stabel J, Lambertz A (April 27, 2004). "Efficacy of Pasteurization Conditions for the Inactivation of Mycobacterium avium...
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