...90 are met based on adequate and well-controlled animal studies when the results of those animal.....The rule provides criteria to determine if evidence of effectiveness from efficacy studies.....Thus, circumstances in which the agency will rely on evidence from studies in one animal species to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm (score=100)

FDA AMENDS ITS REGULATIONS TO PROVIDE FOR APPROVAL OF CERTAIN NEW...
...animal studies when human efficacy studies are not ethical or feasible. The agency is taking this.....studies in humans cannot be ethically conducted because the studies would involve.....animal studies and any additional supporting data. Products evaluated for effectiveness..
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00811.html (score=85)

FDA Proposes Draft Guidance on Medical Products to Treat Radiation Contamination
...The guidance provides advice on what studies sponsors need to perform to evaluate new.....Animal Efficacy Rule, which took effect in 2002, could be used to facilitate development of new.....This rule applies when adequate and well-controlled clinical studies in humans cannot be..
http://www.fda.gov/bbs/topics/news/2005/NEW01157.html (score=73)

Internal Radioactive Contamination--Development of Decorporation Agents
...Preliminary or exploratory animal efficacy studies, typically in rodents or other suitable small animal.....In FDA's experience, animal efficacy studies found in the published literature or conducted without the.....Under the Animal Efficacy Rule, a sponsor can rely on animal studies to provide substantial evidence of effectiveness for certain new..
http://www.fda.gov/cder/guidance/6394dft.htm (score=69)

þÿ
...adequate and well-controlled animal studies, the ..results of which establish that the product is.....In some cases, prior to animal efficacy trials, for concurrence with concepts. ­ Following Agency.....All studies subject to this Rule must be conducted in ..accordance with preexisting..
http://www.fda.gov/cber/summaries/plague101304ma.pdf (score=57)

CDER 2003 Report to the Nation
...Natural history, pharmacokinetic and toxicology studies were performed to support planned efficacy studies using a non-human primate.....The traditional tools used to assess product safety-animal toxicology and outcomes from.....The current drug discovery process, based on in-vitro screening techniques and animal..
http://www.fda.gov/cder/reports/rtn/2003/rtn2003.htm (score=55)

þÿ
...can appropriately be used for approval, these provisions for use of animal studies do not apply.....demonstrate efficacy, confirmatory clinical studies will be expected for verification of.....The contribution of animal data to efficacy evaluations will vary according to numerous..
http://www.fda.gov/cder/guidance/5518dft.pdf (score=54)

Guidance for Industry: Vaccinia Virus — Developing Drugs to Mitigate...
...Also, if approval is given based upon efficacy data from animal models, postmarketing studies must be.....We also expect that animal studies describing the pharmacological effects and mechanisms of.....Therefore, animal models may provide a source of supportive efficacy data, or possibly..
http://www.fda.gov/cber/gdlns/vacciniadrugs.htm (score=54)

Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate...
...can appropriately be used for approval, these provisions for use of animal studies do not apply.....demonstrate efficacy, confirmatory clinical studies will be expected for verification of.....The contribution of animal data to efficacy evaluations will vary according to numerous..
http://www.fda.gov/cber/gdlns/vacciniadrugs.pdf (score=54)

National Foundation for Infectious Diseases: Seventh Annual Vaccines...
...Use of animal efficacy data for approval.. The Challenge of Bioterrorism: the Animal Rule.....Carry out studies with a strain to which .. the population is naïve (such as H5) Speeding.....Approval under the "animal" rule· Attention to risk:benefit and risk management .. issues..
http://www.fda.gov/cber/summaries/nfid052404we.pdf (score=39)

World Vaccine Congress: Routes to Expedite Vaccine Approvals
...Use of animal efficacy data for approval.. The "Animal Rule" This rule will apply when adequate.....the studies would involve administering a .. potentially lethal or permanently disabling.....potential for multiple cycles of review) · Formal mechanisms· Approval under the "animal..
http://www.fda.gov/cber/summaries/worldvacc101104we.pdf (score=39)

FR Notice New Drug and Biological Drug Products; Evidence Needed to...
...90 are met based on adequate and well-controlled animal studies when the results of those animal.....The rule provides criteria to determine if evidence of effectiveness from efficacy studies.....Thus, circumstances in which the agency will rely on evidence from studies in one animal species to..
http://www.fda.gov/cber/rules/humeffic.htm (score=39)

New Drug and Biological Drug Products; Evidence Needed to Demonstrate...
...toxicity of chemical, biological, preexisting requirements under the good postmarketing.....more than one animal species unless the single animal species using a well- that antivenin.....efficacy studies. be applied to protect the public health. limited by requiring new..
http://www.fda.gov/cber/rules/humeffic.pdf (score=35)

Document
...toxicity of chemical, biological, preexisting requirements under the good postmarketing.....more than one animal species unless the single animal species using a well- that antivenin.....efficacy studies. be applied to protect the public health. limited by requiring new..
http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.pdf (score=26)

STATEMENT BY KATHRYN C. ZOON, PH.D
...More recent data on animal efficacy was published in summary form by Arthur Friedlander, M.....Efficacy Studies in Humans Ethically Cannot Be Conducted, Federal Register Volume 64 53960-70, 1999.....animal data to provide efficacy data to support FDA approval when scientifically..
http://www.fda.gov/ola/2000/anthraxvaccine2.html (score=23)

News Along the Pike December 2003 Issue
...Natural history, pharmacokinetic and toxicology studies were performed to support planned efficacy studies utilizing a non-human.....animal efficacy rule.” The rule allows use of animal data for evidence of a drug’s.....This is generally a point before a sponsor studies special populations such as children or..
http://www.fda.gov/cder/pike/dec2003.htm (score=23)

CDER 2004 Report to the Nation
...Natural history studies, pharmacokinetic and toxicology studies to support efficacy studies and efficacy studies with.....animal models and in humans. These will help detect the very earliest damage that can be.....We monitor changes in manufacturing to make sure they won’t adversely affect safety or..
http://www.fda.gov/cder/reports/rtn/2004/rtn2004.htm (score=22)

Part 1, Goals, FY 2003 Annual Performance Plan
...animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically.....This strategy also addresses the efficacy of devices that are used to detect the presence.....Publish a Notice of Proposed-Rulemaking to establish a web-based electronic animal and..
http://www.fda.gov/ope/fy03plan/goals.html (score=22)

Counterterrorism
...animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically.....animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically.....This strategy also addresses the efficacy of devices that are used to detect the presence..
http://www.fda.gov/oc/mcclellan/counterterrorism.html (score=22)

News Along the Pike, January-February 2002
...The new rule will apply when adequate and well-controlled clinical studies in humans.....animal efficacy rule and the move of CDER's renamed Office of Counterterrorism and Pediatric Drug.....Expanded studies have a very important place, the team just complements ongoing research..
http://www.fda.gov/cder/pike/july2002.htm (score=22)

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