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Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
7th grade V bad
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New words:
ABSUSE, acombinationofself, actionagainst, actionshasincreased, actualdamagessustained, Actwhich, adequatelydemonstrate, adistractiontomanagement, adoptedlawsand, advancebytheFDA, adverseeffect, advisorsand, aFalse, affectour, affiliated, afterapprovalthan, Afuturerecallannouncement, againstsuch, againstusifsuchrecall, alsolimit, Althoughwecannotpredictthefulleffecton, Anassessmentbya, andadverseeventreportingfor, andfederal, andfurtherdefine, andfuture, andimplementingmanufacturingmethodsandbuilding, andisusingour, andmaybeapprovedon, andother, andpatentapplicationsmaybesubjectto, andtheoutcome, andtime, andtocomply, andTrademark, andwe, Anyadverseeffectsobservedaftermarketing, anymaterial, anyofourpendingorfuture, Anyoftheseproceedingscouldresult, anyofwhich, apilotcGMPcompliantfacilityinHungaryto, applicationsareissued, applyto, approvedcommercial, approvedin, areaofproductionand, arediscovered, arerequired, aresuccessfulindefending, Asacondition, Asaresult, asclinicalexperience, asignificantnumber, asinspectionorenforcement, Asof, asplanned, asthe, authoritieshavetheauthority, bansor, beable, becapable, becommercially, becommerciallyviable, beconductedundertheoversightofanIRBforthe, beforehumanclinicaltrialsmaybeginandwhichmustincludeInstitutional, beharmed, behavior, benefitand, benefitoverexistingtreatmentsmayreceiveacceleratedapproval, benoassurance, beobservedafterapproval, besubjectto, biologicsandmedical, byour, bythe, candidateandunderwhatlegalauthoritytheproductcandidate, candidatenotto, cannotmanufacturethe, cannotsellanyproductandwillhavenoproduct, canresult, causetheapprovedproduct, certainaspectsofproductsdeveloped, chain, chooseto, clinicaltrialatany, Clinicaltrialsaresubjectto, clinicaltrialsfailto, clinicaltrialsitesandmust, Clinicaltrialsmust, clinicaltrialsorother, clinicaltrialstoverify, closure, complieswithbothFDA, conditionand, confirmtheearly, Conrad, consentin, costsand, costsandbe, couldharmour, datamay, delayedclinicaltrialsofother, delaysinregulatory, DermaViranditscomponentsandfor, developequivalent, deviceor, deviceswereto, dialogue, difficultfor, directivesand, distributedthroughoutthe, distributethe, drugormedicaldevice, effectsand, endpointotherthan, enforcementaction, enrollpatientsin, establishingthatthedrugproduct, Evenifwe, eventstothe, expandsafterapprovalor, extensivemonitoring, FDAapprovaloftheBLA, FDAcould, FDAmay, FDAor, Fiberscan, filingorcausingtobefiledafalseclaim, finalDermaVirproduct, foraCEmarking, foraspecified, Foreignpatentsmaybesubjecttooppositionorcomparable, fromknowingly, fromthetrade, greaternumberandmore, greatest, grocery, healthcarecompaniestohavetodefend, hireandtrain, Ifanentityisdeterminedtohaveviolated, ifthemalfunctionof, Ifwefail, Ifwefailindefending, IIclinicaltestingonalimitednumberofsubjectsasdescribedbelow, illegallyobtained, illnessesandthat, importorexport, increaseddevelopment, indevelopment, individualonbehalfofthe, inexistingdrugtherapy, infuture, injury, inorderforamanufacturer, institutionappointedtoconductconformity, INTERAL, intermediate, IRBcouldsuspenda, irreversiblemorbidity, isalsouncertain, isexpensive, issuedbytheInternational, isunpredictable, itmore, labelingandpackagingfortheproduct, largerquantitiesofourImmune, left, Litigationmaybenecessarytodefendagainst, localethicscommittee, maintaincompliance, majorcountriesinEurope, malfunctionedinaway, malfunctionin, malignant, manufacturedthe, Manufacturersmay, manufacturersmust, manufacturingfacilityorfacilitiesatwhichthe, marketandsellourproductcandidatesprofitably, marketaparticular, marketingofourproductcandidatesaresubjecttoextensiveregulationbygovernmental, maylose, Medicaidandotherstate, meetdemand, memory, Mir, multiplied, narrowedduring, notseenoranticipated, obtainFDA, ofadrugreceiving, ofanapprovedBLAarerequiredtokeepextensive, ofaneffect, ofarelevantdirectivewillbe, ofbeingmanufactured, ofconformity, ofemployeesand, ofkey, ofour, ofourclinical, ofourtime, ofpatentlawsmayalsodiminishthevalueofourintellectual, ofsuch, oftheformer, oftheproduct, ofunauthorized, onaclinical, onourfinancial, ontherateofpatientenrollment, onthetypeandclassofthe, operatingour, orany, orbederived, orcontributed, orcustomer, orderustopaysubstantialdamagesand, orifthe, orifwefail, orinvoluntary, ormandatory, ormanufacturing, ormayhave, ormaynotresultinpatentsbeingissued, ornarrow, orother, orotherwise, orpersonnel, orpreventourability, orpreviously, ortheir, orto, orwillfullydisclose, otherapplicable, otherproblemsmay, otherproductcandidate, otherproprietaryinformation, ourability, ourclinical, ourconfidential, ourmedicaldeviceproductscauseorcontribute, particularlyformedical, partiesforcertainaspectsof, partnersby, patentsandpatent, patentsthatweownorlicensemayprovidelimited, patientenrollment, patientpopulationmay, penaltiesranging, predominantly, privacyandhumansubject, proceedingsin, processesand, processesandother, processesare, productcould, productdeviation, productfromthemarketplace, productsalsocould, productscouldadverselyimpacthowmuchorunderwhatcircumstanceshealthcareproviderswillprescribeor, productsforthetreatment, productsin, productsstudiedfortheirsafetyandeffectivenessintreating, productthroughout, proprietaryinformation, prospectscouldbemateriallyadverselyaffected, providemeaningfultherapeutic, PublicHealthServiceAct, qualitycontrolto, recallswithinrequired, redemption, reexamination, regulationsthatmirrorthoseof, regulatoryrequirementsoftheFDAandother, reimbursedunder, remainwith, reportthe, reportthese, reputationandfinancial, reputationwithcustomersandnegatively, requirean, requirementsandstate, requirementsconcerningadvertisingandpromotionallabeling, requirementsforcostly, requirementsrelatingto, requirethat, requirethededication, researchpersonnel, respectto, resultinsubstantial, resultsof, revaluation, safeguardourproprietary, safetyandefficacy, safetyprofile, satisfactorycompletionofanFDAinspectionofthe, satisfactoryreviewof, secretsorother, seenduring, seriousinjuryor, seteny, similarlawsmodeledafter, sponsoredby, stateshavealsoenacted, submissionto, substancethat, substantialcompetition, takeenforcement, technicalknowledgeandmanagementandindustryexpertiseofanyofourkey, technologiesarefoundtoincorporate, testingmaynot, thatadevice, thatanyofour, thatareessential, thatathirdparty, thatisreasonablylikely, thatwere, thatwould, theaccelerated, theapproved, thebasisof, theclinical, thecontentsof, thedevice, theevent, theFDAand, TheFederal, theministry, Therateofcompletion, Therecan, therehavebeenanumberof, Theremaybe, therequired, thescopeof, Thesestepsmayrequireadditionalresourcesandcouldbecostly, thesponsorfailsto, theymaynotprovideuswithadequateprotectionorany, thirdpartiesmaybeable, thirdpartyassessmentconsistsofanaudit, Thiscompetition, Thiscouldmateriallyandadverselyimpactourbusinessbyreducingourabilityto, timefor, toadeath, toadeathor, toadministrative, tocommercially, tocompete, tocomply, tocomplywithanumber, todevelop, toexpend, tomonitorthesafety, toour, topredict, toreport, torequiretherecallof, totakeadditionalstepsinthedevelopmentandmanufactureof, totalorpartialsuspension, totheFDAinformation, touseourproprietary, trademarksandunpatented, trialmanufacture, trialsmaybeinitiated, trialswilldepend, Unauthorizedpartiesmayalsoattempttocopyorreverseengineer, underforeign, unsuccessful, usedbya, usedordisclosedtrade, useoforwithdrawal, usesofour, usorourcollaboration, variesdepending, voluntary, wecould, wecouldbesubject, wefailto, wemust, Werelyonacombination, whethervoluntary, whichcanresultinvoluntarycorrective, whichcould, willreceiveacceleratedapproval, withabiologic, withany, withcGMPandotheraspectsofregulatorycompliance, withdrawsuchapprovalif, withormirror, Withoutlimitingthegeneralityof, withthe, withtheessential
Removed:
Amendment, appointed, Eugene, factor, manage, rapid, released, remediate, resolution, today
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