us fda finalises rule allowing drug approval based on animal efficacy data

Inpharma 1349 - 3 Aug 2002 ■ The US FDA has finalised a rule that allows drug approval to be sought based on animal efficacy data, according to a report in Applied Clinical Trials. The rule applies to drugs to be used for prevention or treatment in individuals exposed to toxic substances, that cannot be tested in humans for ethical reasons. Human safety data will still be required and efficacy tests should involve more than one animal species, although multiple models are not necessary. The rule also requires the FDA to preclear promotional materials on the drugs in question. According to the report, the FDA expects to utilise the rule less than once a year. Wechsler J. FDA finalizes animal rule for drug approval. Applied Clinical Trials 11: 24, Jul 2002 800901381 1 Inpharma 3 Aug 2002 No. 1349 1173-8324/10/1349-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: US FDA finalises rule allowing drug approval based on animal efficacy data

Inpharma 1349 - 3 Aug 2002

■ The US FDA has finalised a rule that allows drugapproval to be sought based on animal efficacy data,according to a report in Applied Clinical Trials. The ruleapplies to drugs to be used for prevention ortreatment in individuals exposed to toxic substances,that cannot be tested in humans for ethical reasons.Human safety data will still be required and efficacytests should involve more than one animal species,although multiple models are not necessary. The rulealso requires the FDA to preclear promotionalmaterials on the drugs in question. According to thereport, the FDA expects to utilise the rule less thanonce a year.Wechsler J. FDA finalizes animal rule for drug approval. Applied ClinicalTrials 11: 24, Jul 2002 800901381

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