RAC DRUGS PRACTICE EXAM WITH FULL PACK
SOLUTIONS
1.One dmonth dprior dto dthe danticipated dapproval ddate dfor dyour dproduct,
dthe dmarketing dapplication dthat dyou dsubmitted dto da dmajor dregulatory
dauthority dhas dbecome dthe dsubject dof dan dadvisory dcommittee dmeeting dof
dexperts dconvened dby dthe dregulatory dauthority. dThe dadvisory dcommittee
dmembers dunanimously dvote dnot dto dapprove dyour dproduct dbecause dof da
dsafety dconcern. dTwo ddays dafter dthe dadvisory dcommittee dmeeting, dthe
dregulatory dauthority drequests dadditional dinformation dto dsupport dthe
dsafety dof dyour dproduct. dAssuming dyou dhave dno daddi- dtional ddata dto
dprovide, dwhich dof dthe dfollowing dwould dbe dyour dMOST dappropriate
dresponse dto dthe dregulatory dauthority's drequest?: dSee dnext dcard
2.1. d"Given dthe dadvisory dcommittee's dunanimous ddecision, dwe dknow dthat
dthe dproduct dwill dnot dbe dapproved, dand dadditional ddata dwill dnot dmake dany
ddifference.
1 d/
d61
,2. "We dhave dno dadditional dinformation dto dprovide dat dthis dtime, dbut dwe
dcan dperform dan dadditional danalysis dfor da dspecific dsafety dconcern, dif
dnecessary."
3. "We ddisagree dwith dthe dadvisory dcommittee's ddecision dbecause dthe
dcommit- dtee dneglected dthe dthorough dsafety danalysis dthat dwe dprovided."
4. "We dhave dno dadditional dinformation dto dprovide dat dthis dtime dbecause dwe
dhave dalready dprovided deverything dneeded dto dsupport dour dproduct's
dapproval.": d2. dWe dhave dno dadditional dinformation dto dprovide dat dthis
dtime, dbut dwe dcan dperform dan dadditional danalysis dfor da dspecific
dsafety dconcern, dif dnecessary
3.Which dof dthe dfollowing dresponsibilities dis dspecifically dassigned dto dthe
dQual- dified dPerson d(QP) dduring dthe dbatch drelease dprocess?
1. The dQP dmust densure dthat dall dmanufacturing dprocesses dare dcompleted
dbefore dbatch drelease.
2. The dQP dis dtasked dwith dverifying dthat dthe dbatch dmeets dthe
dspecifications doutlined din dthe dMarketing dAuthorization.
3. The dQP dis dresponsible dfor dconducting dclinical dtrials dfor dthe dproduct.
4. The dQP dmust doversee dthe dmarketing dstrategies dfor dthe dproduct.: d2. dThe
dQP dis dtasked dwith dverifying dthat dthe dbatch dmeets dthe dspecifications
doutlined din dthe dMarketing dAuthorization
4.What dis dthe drequired dduration dof dcontinuous dadministration din dmonths
dthat dnecessitates dthe devaluation dof dcarcinogenic dpotential dfor
dpharmaceutical dprod- ducts?
1. 3 dmoths
2. 6 dmonths
3. 12 dmonths
4. 24 dmonths: d2. d6 dmonths
2 d/
d61
,5.A dsponsor dis dplanning dto dinitiate da dpivotal dclinical dstudy dfor da ddrug-
lead dcombination dproduct d(e.g. dprefilled dsyringe, dautoinjector, detc.). dFor
dthe ddevice dconstituent dof dthe dcombination dproduct, dwhat's dthe dFDA
dminimum dregulatory drequirement dthat dmust dbe dmet dprior dto dintroducing
dthe dcombination dproduct dinto dthe dclinical dstudy?
1. Meet dcombination dproduct dcGMP drequirements
2. Meet dthe dusability dhuman dfactors drequirement.
3. Meet dthe ddesign dcontrols drequirement daccording dto d21 dCFR dpart
d820.30, dunless dthe ddevice dconstituent dis dexempt dfrom ddesign dcontrols
drequirements.
4. Meet dthe dEU dMDR dGeneral dSafety dand dPerformance: d3. dMeet dthe ddesign
dcontrols drequirement daccording dto d21 dCFR dPart d820.30, dunless dthe
ddevice dconstituent dis dexempt dfrom ddesign dcontrols drequirements.
6.Which dof dthe dfollowing dis dfalse dregarding dFDA dexpedited dprograms?
1. The dlevel dof devidence drequired dfor dFast dTrack dDesignation dis dless
dthan dfor dBreakthrough dTherapy dDesignation?
2. Breakthrough dTherapy dDesignation dand dRMAT dDesignation drequire
devidence dthat dthe ddrug dmay doffer da dsubstantial dimprovement drelative dto
davailable dthera- dpies.
3. RMAT dDesignation dshould dbe drequested dwith dthe dIND dor dlater, dbut dno
dlater dthan dthe dEOP2 dmeeting.
4. Fast dTrack dDesignation, dBreakthrough dTherapy dDesignation, dand dRMAT
dDes- dignation dmay dbe drescinded dlater din dproduct ddevelopment.: d2.
dBreakthrough dTherapy dDesignation dand dRMAT dDesignation drequire
devidence dthat dthe ddrug dmay doffer da dsubstantial dimprovement
drelative dto davailable dtherapies.
7.You dare da dmanufacturer din dthe dUS, dand dyou ddiscover dthat dyour
dcompany's dtop dselling dproduct din dthe dlast dtwo dyears dhas dbeen dused doff-
label. dThe doff-label duse dis destimated dto dbe dabout d70%, dand dit dhas dbeen
dconsistent dsince dthe dproduct dwas dfirst dreleased dto dthe dmarket. dWhich dof
dthe dfollowing dis dthe dMOST dappropriate dnext dstep?
1. file da dreport dto dregulatory dauthorities dand dadvise dthe dmarketing
ddepartment dto dprevent dfuture doff-label duse.
2. Discuss dwith dregulatory dauthorities dto dinvestigate dhow dto dhave dthe doff-
label dindication dapproved.
3. Discuss dthe doff-label duse dwith dKey dOpinion dleaders d(KOLs) dto ddetermine
3 d/
d61
, dhow dmany dpatients dwould dbenefit dfrom dthe dapproval dof dthe ddrug.
5. dNo daction dis drequired dsince dit dis dan doff-label duse. dclinicians dhave dthe
dfreedom
4 d/
d61
SOLUTIONS
1.One dmonth dprior dto dthe danticipated dapproval ddate dfor dyour dproduct,
dthe dmarketing dapplication dthat dyou dsubmitted dto da dmajor dregulatory
dauthority dhas dbecome dthe dsubject dof dan dadvisory dcommittee dmeeting dof
dexperts dconvened dby dthe dregulatory dauthority. dThe dadvisory dcommittee
dmembers dunanimously dvote dnot dto dapprove dyour dproduct dbecause dof da
dsafety dconcern. dTwo ddays dafter dthe dadvisory dcommittee dmeeting, dthe
dregulatory dauthority drequests dadditional dinformation dto dsupport dthe
dsafety dof dyour dproduct. dAssuming dyou dhave dno daddi- dtional ddata dto
dprovide, dwhich dof dthe dfollowing dwould dbe dyour dMOST dappropriate
dresponse dto dthe dregulatory dauthority's drequest?: dSee dnext dcard
2.1. d"Given dthe dadvisory dcommittee's dunanimous ddecision, dwe dknow dthat
dthe dproduct dwill dnot dbe dapproved, dand dadditional ddata dwill dnot dmake dany
ddifference.
1 d/
d61
,2. "We dhave dno dadditional dinformation dto dprovide dat dthis dtime, dbut dwe
dcan dperform dan dadditional danalysis dfor da dspecific dsafety dconcern, dif
dnecessary."
3. "We ddisagree dwith dthe dadvisory dcommittee's ddecision dbecause dthe
dcommit- dtee dneglected dthe dthorough dsafety danalysis dthat dwe dprovided."
4. "We dhave dno dadditional dinformation dto dprovide dat dthis dtime dbecause dwe
dhave dalready dprovided deverything dneeded dto dsupport dour dproduct's
dapproval.": d2. dWe dhave dno dadditional dinformation dto dprovide dat dthis
dtime, dbut dwe dcan dperform dan dadditional danalysis dfor da dspecific
dsafety dconcern, dif dnecessary
3.Which dof dthe dfollowing dresponsibilities dis dspecifically dassigned dto dthe
dQual- dified dPerson d(QP) dduring dthe dbatch drelease dprocess?
1. The dQP dmust densure dthat dall dmanufacturing dprocesses dare dcompleted
dbefore dbatch drelease.
2. The dQP dis dtasked dwith dverifying dthat dthe dbatch dmeets dthe
dspecifications doutlined din dthe dMarketing dAuthorization.
3. The dQP dis dresponsible dfor dconducting dclinical dtrials dfor dthe dproduct.
4. The dQP dmust doversee dthe dmarketing dstrategies dfor dthe dproduct.: d2. dThe
dQP dis dtasked dwith dverifying dthat dthe dbatch dmeets dthe dspecifications
doutlined din dthe dMarketing dAuthorization
4.What dis dthe drequired dduration dof dcontinuous dadministration din dmonths
dthat dnecessitates dthe devaluation dof dcarcinogenic dpotential dfor
dpharmaceutical dprod- ducts?
1. 3 dmoths
2. 6 dmonths
3. 12 dmonths
4. 24 dmonths: d2. d6 dmonths
2 d/
d61
,5.A dsponsor dis dplanning dto dinitiate da dpivotal dclinical dstudy dfor da ddrug-
lead dcombination dproduct d(e.g. dprefilled dsyringe, dautoinjector, detc.). dFor
dthe ddevice dconstituent dof dthe dcombination dproduct, dwhat's dthe dFDA
dminimum dregulatory drequirement dthat dmust dbe dmet dprior dto dintroducing
dthe dcombination dproduct dinto dthe dclinical dstudy?
1. Meet dcombination dproduct dcGMP drequirements
2. Meet dthe dusability dhuman dfactors drequirement.
3. Meet dthe ddesign dcontrols drequirement daccording dto d21 dCFR dpart
d820.30, dunless dthe ddevice dconstituent dis dexempt dfrom ddesign dcontrols
drequirements.
4. Meet dthe dEU dMDR dGeneral dSafety dand dPerformance: d3. dMeet dthe ddesign
dcontrols drequirement daccording dto d21 dCFR dPart d820.30, dunless dthe
ddevice dconstituent dis dexempt dfrom ddesign dcontrols drequirements.
6.Which dof dthe dfollowing dis dfalse dregarding dFDA dexpedited dprograms?
1. The dlevel dof devidence drequired dfor dFast dTrack dDesignation dis dless
dthan dfor dBreakthrough dTherapy dDesignation?
2. Breakthrough dTherapy dDesignation dand dRMAT dDesignation drequire
devidence dthat dthe ddrug dmay doffer da dsubstantial dimprovement drelative dto
davailable dthera- dpies.
3. RMAT dDesignation dshould dbe drequested dwith dthe dIND dor dlater, dbut dno
dlater dthan dthe dEOP2 dmeeting.
4. Fast dTrack dDesignation, dBreakthrough dTherapy dDesignation, dand dRMAT
dDes- dignation dmay dbe drescinded dlater din dproduct ddevelopment.: d2.
dBreakthrough dTherapy dDesignation dand dRMAT dDesignation drequire
devidence dthat dthe ddrug dmay doffer da dsubstantial dimprovement
drelative dto davailable dtherapies.
7.You dare da dmanufacturer din dthe dUS, dand dyou ddiscover dthat dyour
dcompany's dtop dselling dproduct din dthe dlast dtwo dyears dhas dbeen dused doff-
label. dThe doff-label duse dis destimated dto dbe dabout d70%, dand dit dhas dbeen
dconsistent dsince dthe dproduct dwas dfirst dreleased dto dthe dmarket. dWhich dof
dthe dfollowing dis dthe dMOST dappropriate dnext dstep?
1. file da dreport dto dregulatory dauthorities dand dadvise dthe dmarketing
ddepartment dto dprevent dfuture doff-label duse.
2. Discuss dwith dregulatory dauthorities dto dinvestigate dhow dto dhave dthe doff-
label dindication dapproved.
3. Discuss dthe doff-label duse dwith dKey dOpinion dleaders d(KOLs) dto ddetermine
3 d/
d61
, dhow dmany dpatients dwould dbenefit dfrom dthe dapproval dof dthe ddrug.
5. dNo daction dis drequired dsince dit dis dan doff-label duse. dclinicians dhave dthe
dfreedom
4 d/
d61
