FOOD AND DRUG ADMINISTRATION Defense

 Essay in FDA Defense

BetweenВ 2002В andВ 2004В aВ companyВ namedВ SynthesВ testedВ aВ productВ calledВ NorianВ XRВ inВ certainВ spineВ surgeriesВ killingВ atВ leastВ fiveВ patients. В AsВ theВ defense, В weВ asВ attorneys, В haveВ theВ taskВ ofВ defendingВ theВ FDA, В whomВ hadВ aВ clearВ patternВ ofВ explicitlyВ tellingВ Synthes'В executivesВ thatВ NorianВ XRВ wasВ notВ clearВ orВ approvedВ forВ theВ useВ ofВ VCFВ surgeryВ (vertebralВ compressionВ fracture). В UponВ examiningВ thisВ case, В thereВ areВ severalВ piecesВ ofВ informationВ thatВ willВ beВ pointedВ outВ whichВ proveВ theВ innocenceВ ofВ theВ FDAВ andВ alsoВ showВ theВ eventsВ thatВ transpiredВ afterwardsВ whichВ strengthenВ thatВ argument. В HoweverВ theВ mainВ pointВ ofВ thisВ defenseВ andВ argumentВ isВ toВ showВ howВ throughВ thisВ tragicВ seriesВ ofВ events, В thatВ aВ newlyВ restructuredВ FDAВ canВ beВ theВ product. В FirstВ isВ theВ examinationВ ofВ howВ theВ FDAВ isВ aВ broadВ agency, В andВ thatВ theВ scopeВ andВ amountВ ofВ resourcesВ theyВ haveВ isВ limited. В NextВ isВ theВ examinationВ ofВ theВ offВ labelВ useВ ofВ prescriptionВ drugs, В andВ theВ penaltiesВ thatВ shouldВ beВ incorporatedВ forВ violationsВ ofВ thisВ policy. В LastlyВ isВ theВ issueВ ofВ vestingВ betweenВ governmentВ agenciesВ andВ theВ privateВ sector, В especiallyВ inВ casesВ likeВ this, В thereВ needsВ toВ beВ someВ strictВ guidelinesВ asВ toВ preventВ incidentsВ likeВ thisВ fromВ happeningВ inВ theВ futureВ asВ well. В

FirstВ isВ someВ backgroundВ onВ theВ case, В andВ aВ briefВ descriptionВ ofВ whatВ wasВ happening. В В SynthesВ isВ aВ MedicalВ deviceВ makerВ thatВ wasВ acquiredВ byВ JohnsonВ andВ Johnson. В В ThisВ companyВ inВ 2009В wasВ accusedВ ofВ runningВ illegalВ clinicalВ trialsВ onВ humansВ betweenВ 2002В andВ 2004В forВ aВ productВ calledВ NorianВ XRВ inВ termsВ ofВ offВ labelВ use. В ThisВ NorianВ XRВ productВ thatВ SynthesВ hadВ cameВ outВ withВ hadВ seemedВ likeВ aВ wonderВ drugВ, inВ thatВ itВ hadВ theВ capacityВ toВ turnВ intoВ boneВ whenВ injectedВ inВ theВ humanВ skeleton. В HoweverВ theВ problemВ ofВ NorianВ XRВ isВ thatВ whenВ itВ hitsВ theВ bloodstream, В theВ patientВ diesВ veryВ quickly, В bloodВ clottingВ inВ theВ heartВ beingВ theВ issue. В SynthesВ wasВ awareВ ofВ NorianВ XRВ...


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