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RAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWERS

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RAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWERSRAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWERSVRAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWERSRAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWERSRAC Drugs Practice Exam 2024 QUESTIONS WITH VERIFIED ANSWE...

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RAC DRUGS PRACTICE EXAM 2024 QUESTIONS WITH VERIFIED
ANSWERS

pplication ythat yyou ysubmitted yto ya ymajor yregulatory yauthority yhas ybecome ythe
ysubject yof yan yadvisory ycommittee ymeeting yof yexperts yconvened yby ythe yregulatory
yauthority. yThe yadvisory ycommittee ymembers yunanimously yvote ynot yto yapprove
yyour yproduct ybecause yof ya ysafety yconcern. yTwo ydays yafter ythe yadvisory
ycommittee ymeeting, ythe yregulatory yauthority yrequests yadditional yinformation yto
ysupport ythe ysafety yof yyour yproduct. yAssuming yyou yhave yno yadditional ydata yto
yprovide, ywhich yof ythe yfollowing ywould ybe yyour yMOST yappropriate yresponse yto ythe
yregulatory yauthority's yrequest? y- yCorrect y yAnswer y- ySee ynext ycard
1. y"Given ythe yadvisory ycommittee's yunanimous ydecision, ywe yknow ythat ythe yproduct
ywill ynot ybe yapproved, yand yadditional ydata ywill ynot ymake yany ydifference.
2. y"We yhave yno yadditional yinformation yto yprovide yat ythis ytime, ybut ywe ycan yperform
yan yadditional yanalysis yfor ya yspecific ysafety yconcern, yif ynecessary."
3. y"We ydisagree ywith ythe yadvisory ycommittee's ydecision ybecause ythe ycommittee
yneglected ythe ythorough ysafety yanalysis ythat ywe yprovided."
4. y"We yhave yno yadditional yinformation yto yprovide yat ythis ytime ybecause ywe yhave
yalready yprovided yeverything yneeded yto ysupport your yproduct's yapproval." y- yCorrect y
yAnswer y- y2. yWe yhave yno yadditional yinformation yto yprovide yat ythis ytime, ybut ywe
ycan yperform yan yadditional yanalysis yfor ya yspecific ysafety yconcern, yif ynecessary
A ysponsor yis yplanning yto yinitiate ya ypivotal yclinical ystudy yfor ya ydrug-lead
ycombination yproduct y(e.g. yprefilled ysyringe, yautoinjector, yetc.). yFor ythe ydevice
yconstituent yof ythe ycombination yproduct, ywhat's ythe yFDA yminimum yregulatory
yrequirement ythat ymust ybe ymet yprior yto yintroducing ythe ycombination yproduct yinto
ythe yclinical ystudy?

1. yMeet ycombination yproduct ycGMP yrequirements
2. yMeet ythe yusability yhuman yfactors yrequirement.
3. yMeet ythe ydesign ycontrols yrequirement yaccording yto y21 yCFR ypart y820.30, yunless
ythe ydevice yconstituent yis yexempt yfrom ydesign ycontrols yrequirements.
4. yMeet ythe yEU yMDR yGeneral ySafety yand yPerformance y- yCorrect y yAnswer y- y3.
yMeet ythe ydesign ycontrols yrequirement yaccording yto y21 yCFR yPart y820.30, yunless
ythe ydevice yconstituent yis yexempt yfrom ydesign ycontrols yrequirements.
Which yof ythe yfollowing yis yfalse yregarding yFDA yexpedited yprograms?

1. yThe ylevel yof yevidence yrequired yfor yFast yTrack yDesignation yis yles ythan yfor
yBreakthrough yTherapy yDesignation?
2. yBreakthrough yTherapy yDesignation yand yRMAT yDesignation yrequire yevidence
ythat ythe ydrug ymay yoffer ya ysubstantial yimprovement yrelative yto yavailable ytherapies.
y
3. yRMAT yDesignation yshould ybe yrequested ywith ythe yIND yor ylater, ybut yno ylater
ythan ythe yEOP2 ymeeting. y

,4. yFast yTrack yDesignation, yBreakthrough yTherapy yDesignation, yand yRMAT
yDesignation ymay ybe yrescinded ylater yin yproduct ydevelopment. y- yCorrect y yAnswer y-
y2. yBreakthrough yTherapy yDesignation yand yRMAT yDesignation yrequire yevidence
ythat ythe ydrug ymay yoffer ya ysubstantial yimprovement yrelative yto yavailable ytherapies.
You yare ya ymanufacturer yin ythe yUS, yand yyou ydiscover ythat yyour ycompany's ytop
yselling yproduct yin ythe ylast ytwo yyears yhas ybeen yused yoff-label. yThe yoff-label yuse yis
yestimated yto ybe yabout y70%, yand yit yhas ybeen yconsistent ysince ythe yproduct ywas
yfirst yreleased yto ythe ymarket. yWhich yof ythe yfollowing yis ythe yMOST yappropriate ynext
ystep?

1. yfile ya yreport yto yregulatory yauthorities yand yadvise ythe ymarketing ydepartment yto
yprevent yfuture yoff-label yuse.
2. yDiscuss ywith yregulatory yauthorities yto yinvestigate yhow yto yhave ythe yoff-label
yindication yapproved.
3. yDiscuss ythe yoff-label yuse ywith yKey yOpinion yleaders y(KOLs) yto ydetermine yhow
ymany ypatients ywould ybenefit yfrom ythe yapproval yof ythe ydrug.
5. yNo yaction yis yrequired ysince yit yis yan yoff-label yuse. yclinicians yhave ythe yfreedom
yto ytreat ytheir ypatients ybased yon ywhat yis ymedically yappropriate. y- yCorrect y yAnswer
y- y2. yDiscuss ywith yregulatory yauthorities yto yinvestigate yhow yto yhave ythe yoff-label
yindication yapproved.
In ythe yEU, ywhich ytype yof ydocumentation yshould yNOT ybe yincluded yin yModule y1 yof
ya ysubmitted ydossier?

1. ySmPC, yLabeling, yand yPackage yleaflet.
2. yEnvironmental yRisk yAssessment. y
3. yQuality yoverall ysummary
4. yRisk ymanagement yplan y- yCorrect y yAnswer y- y3. yQuality yOverall ySummary
To yobtain yapproval yfor yan yANDA, ya ycompany yMUST ymeet ywhich ycriterion?

1. ySubmit yand yreceive yapproval yfor yan yIND
2. yDemonstrate ysafety yand yefficacy yof ythe yproposed y
3. yDemonstrate ybioequivalence ybetween ythe yinnovator ydrug yand ythe yproposed
ygeneric ydrug.
4. yDemonstrate ythe yefficacy yof ythe yinnovator ydrug yand ythe yproposed ygeneric. y-
yCorrect y yAnswer y- y3. yDemonstrate ybioequivalence ybetween ythe yinnovator ydrug
yand ythe yproposed ygeneric ydrug
A yfirm yis ypreparing ya y501(k), ypremarket ynotification yto yFDA yfor yan yin yvitro
ydiagnostic ytest, ya ymicrohematocrit yanalyzer ythat, yamong yother yintended yuses, ycan
ydetermine ya yblood ydonor's yhematocrit yprior yto ydonation. yThe yfirm yshould yaddress
ythe y501(k) ysubmission yto:

1. yCDER
2. yCBER
3. yCDRH
4. yOCP y- yCorrect y yAnswer y- y

, A ycompany yis ydeveloping yan yunapproved ycell yand ygene ytherapy ythat yis ya
ycombination yproduct y(device-biologic). yWhat yapplication yand yto ywhich ycenter
yshould ythe ycompany ysubmit yits yapplication yfor ymarketing yapproval?

1. ySubmit ya yPremarket yNotification yapplication yto yCDRH.
2. ySubmit ya yBiologic yLicense yApplication y(BLA) yto yCDER
3. ySubmit ya yBLA yto yCBER
4. ySubmit yan yInvestigational yNew yDrug yApplication y(IND) ytp yCBER y- yCorrect y
yAnswer y- y
Which yof ythe yfollowing ylabeling yelements yis yNOT yrequired yfor yall yover-the-counter
ydrugs yin ythe yU.S.?

1. yName yand yplace yof ybusiness yof ymanufacturer, ypacker, yor ydistributor?
2. yNet yquantity yof ycontents.
3. yStatement yof yingredients
4. yPregnancy/breast-feeding ywarning. y- yCorrect y yAnswer y- y1. yName yand yplace yof
ybusiness yof ymanufacturer, ypacker, yor ydistributor?
Which yU.S. yagency ymakes ythe yfirst yassessment yof ya ynew ydrug's ypotential yfor
yaddiction yand/or yabuse?

1. yDEA
2. yFDA
3. ySubstance yAbuse yand yMental yHealth yServices yAdministration
4. yNational yInstitute yon yDrug yAbuse y- yCorrect y yAnswer y- yFDA
Which yof ythe yfollowing yis yNOT yan yinvestigator's yresponsibility?

1. ySubmitting yunanticipated yadverse yevent yreports yto yFDA
2. ySubmitting ynotices yto ythe yIRB yof ydeviations yfrom ythe yinvestigational yplan
3. yMaintaining yrecords yof yreceipt, yuse yand ydisposition yof yinvestigational yproduct.
4. yReporting yto ythe ysponsor ywithdrawal yof yIRB yapproval. y- yCorrect y yAnswer y- y1.
ySubmitting yunanticipated yadverse yevent yreports yto yFDA
Which yof ythe yfollowing ychanges yto yan yapproved yNDA ycan ybe yimplemented yprior yto
yFDA yapproval?

1. yElimination yof yunnecessary yin-process ycontrols
2, yExtension yof ythe yexpiration ydate ybased yon yshelf ylife yobtained yfrom ythe ystability
yprotocol yin ythe yapproved yapplication.
3. yImplementation yof ymodifications ythat, yif ydelayed, ywould yimpose yan yextraordinary
yhardship yon ythe yapplicant
4. yUse yof ya ynew yGMP yfacility yto ymanufacture ythe ydrug yproduct. y- yCorrect y
yAnswer y- y2, yExtension yof ythe yexpiration ydate ybased yon yshelf ylife yobtained yfrom
ythe ystability yprotocol yin ythe yapproved yapplication.
A yvideo ypresented yduring ya ydaily ytelevision yshow, yand yaccessible yvia yYouTube,
yfeatured yan yinterview ywith yan yinfluencer/spokesperson, ytalking yabout ythe
yspokesperson's yexperience ywith ya yprescription ymigraine ymedication. yThe yNDA
ysponsor yreceived yan yuntitled yletter yfrom ythe yFDA yoffice yof yPrescription yDrug

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