Third Annual Research, Technologies and Applications in Biodefense
...Human efficacy trials not feasible or ethical.· Use of animal efficacy data scientifically.....Where there is no valid animal model of disease; · How to predictably bridge animal data.....Does not apply if approval can be based on efficacy .. standards elsewhere in FDA..
http://www.fda.gov/cber/summaries/biodef081804ck.pdf (score=100)

FDA APPROVES PYRIDOSTIGMINE BROMIDE AS PRETREATMENT AGAINST NERVE GAS
...FDA believes that, based on the animal evidence of effectiveness, pyridostigmine bromide.....The "animal efficacy rule," which became effective on June 30, 2002, is an important component of.....The "animal efficacy rule" enabled FDA to approve pyridostigmine bromide to increase survival..
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00870.html (score=87)

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 action because it.....animal studies and any additional supporting data. Products evaluated for effectiveness.....ANIMAL EFFICACY DATA .. The Food and Drug Administration has amended its new drug and biological..
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00811.html (score=64)

...600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug.....The procedures in subpart H and in this rule are similar because, to assess efficacy, both.....90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm (score=54)

FDA Proposes Draft Guidance on Medical Products to Treat Radiation Contamination
...Animal Efficacy Rule, which took effect in 2002, could be used to facilitate development of new.....efficacy studies are unethical or not feasible. FDA convened a multidisciplinary group of..
http://www.fda.gov/bbs/topics/news/2005/NEW01157.html (score=52)

Internal Radioactive Contamination--Development of Decorporation Agents
...Preliminary or exploratory animal efficacy studies, typically in rodents or other suitable small.....Even if a new decorporation agent is eligible for approval under the Animal Efficacy Rule, that.....Products evaluated for effectiveness under the Animal Efficacy Rule must be evaluated for safety..
http://www.fda.gov/cder/guidance/6394dft.htm (score=52)

The FDA and the Fight Against Terrorism
...Helping to identify labs that can test feed and animal tissues for the presence of.....Under a new regulation known as "the animal efficacy rule," the FDA can approve medical.....It was the first drug approved under the animal efficacy rule. In January 2002, the FDA also..
http://www.fda.gov/fdac/features/2004/104_terror.html (score=52)

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...The contribution of animal data to efficacy evaluations will vary according to numerous.....amount of efficacy data adequate for drug approval may not be obtainable through clinical.....Next, the guidance focuses on the acquisition of in vivo data through the use of animal..
http://www.fda.gov/cder/guidance/5518dft.pdf (score=42)

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.....The contribution of animal data to efficacy evaluations will vary according to numerous.....Therefore, animal models may provide a source of supportive efficacy data, or possibly..
http://www.fda.gov/cber/gdlns/vacciniadrugs.htm (score=42)

Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate...
...The contribution of animal data to efficacy evaluations will vary according to numerous.....amount of efficacy data adequate for drug approval may not be obtainable through clinical.....Next, the guidance focuses on the acquisition of in vivo data through the use of animal..
http://www.fda.gov/cber/gdlns/vacciniadrugs.pdf (score=42)

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...you want to mention the animal study in the label, then it should be done according to GLP.....In some cases, prior to animal efficacy trials, for concurrence with concepts. ­ Following Agency.....Human Efficacy Studies Are Not Ethical or Feasible.. Request For Comments: 62 FR 40996..
http://www.fda.gov/cber/summaries/plague101304ma.pdf (score=41)

CDER 2003 Report to the Nation
...The traditional tools used to assess product safety-animal toxicology and outcomes from.....This is the first drug approved under the animal efficacy rule. Approved lower doses of the.....The efficacy endpoints in the animal trials are clearly related to human benefit. The drug..
http://www.fda.gov/cder/reports/rtn/2003/rtn2003.htm (score=40)

CDER Report to the Nation: 2001
...Identifying cellular and tissue biomarkers predictive of safety and efficacy, through DNA.....Coordinating with the Department of Defense to develop an appropriate animal model to.....Expediting work on a final regulation that would allow us to rely on animal studies and..
http://www.fda.gov/cder/reports/rtn/2001/rtn2001.htm (score=40)

Vaccines and Biologics: Meeting Product Development Needs to Better Address...
...Guarantee human efficacy based on non-human data such as animal studies or surrogate.....Increase confidence in likely efficacy of products primarily approved based on surrogate.....difficult to establish efficacy, immunological surrogates often unclear ..potential for..
http://www.fda.gov/cber/summaries/aei062702jg.htm (score=29)

Vaccines & Biologics: Meeting Product Development Needs to Better Address...
...Where there is no valid animal model of disease· Confidence may be an issue, even in valid.....Efficacy may be untested, safety database may be limited · Empowerment of individual/legal.....Human efficacy trials not feasible or ethical..· Use of animal efficacy data..
http://www.fda.gov/cber/summaries/aei062702jg.pdf (score=29)

National Foundation for Infectious Diseases: Seventh Annual Vaccines...
...Use of animal efficacy data for approval.. The Challenge of Bioterrorism: the Animal Rule.....Approval under the "animal" rule· Attention to risk:benefit and risk management .. issues.....Efficacy Studies are not Ethical or .. Practical. (The "Animal" Rule) · For new drug and..
http://www.fda.gov/cber/summaries/nfid052404we.pdf (score=28)

World Vaccine Congress: Routes to Expedite Vaccine Approvals
...Use of animal efficacy data for approval.. The "Animal Rule" This rule will apply when adequate.....potential for multiple cycles of review) · Formal mechanisms· Approval under the "animal.....of New Drugs when Human Efficacy Studies are .. not Ethical or Practical. ­ Federal..
http://www.fda.gov/cber/summaries/worldvacc101104we.pdf (score=28)

STATEMENT BY MARK A. ELENGOLD -- OCTOBER 3, 2000
...More recent data on animal efficacy was published in summary form by Arthur Friedlander, M.....There are also relevant non-human primate efficacy data. Previously, data had been..
http://www.fda.gov/ola/2000/anthraxvaccine4.html (score=28)

Drug Preparedness and Response to Bioterrorism
...animal efficacy data.  FDA News. (Posted 6/3/2002) Safety and Effectiveness of Products..
http://www.fda.gov/cder/drugprepare/default.htm (score=28)

FR Notice New Drug and Biological Drug Products; Evidence Needed to...
...600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug.....The procedures in subpart H and in this rule are similar because, to assess efficacy, both.....90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the..
http://www.fda.gov/cber/rules/humeffic.htm (score=17)

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