2002

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…...

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