RAC EXAM PRACTICE WITH VERIFIED
ANSWERS
Which yof ythe yfollowing ywas yNOT ya yrequirement yof ythe yoriginal yFood yDrug yand
yCosmetic yAct yof y1938? ya) yProof yof yefficacy yb) yProof yof ysafety yc) yAuthorized
ystandards yof yidentify yd) ySafe ytolerances yfor yunavoidable ypoisonous
ysubstances(1:1) y- ycorrect yanswers y-A: yProof yof yefficacy
Which yamendments yto ythe yFD&C yAct yresulted yfrom ythe ythalidomide ytragedy? ya)
yDurham-Humphrey yAmendments yb) yHatch-Waxman yAct yc) yControlled ySubstances
yAct yd) yKefauver-Harris yAmendments y(1:2) y- ycorrect yanswers y-D: yKefauver-Harris
yAmendments
The yColor yAdditive yAmendment yof y1960 yrequired yFDA yto yprove ythat ya ycolor
yadditive ywas yunsafe ybefore yremoving yit yfrom ythe ymarket. ya) yTrue yb) yFalse(1:3)
y- ycorrect yanswers y-B: yFalse
,What yhas ybeen ydescribed yas y"the ymost yextensive ychange yto ythe yagency's
ypractices ysince y1938?" ya) yPrescription yDrug yUser yFee yAct yof y1922b) yGMPs yfor
ythe y21st yCentury yinitiative yc) yFood yand yDrug yAdministration yModernization yAct
yd) yFood yand yDrug yAdministration yAmendments yAct(1:4) y- ycorrect yanswers y-C:
yFood yand yDrug yAdministration yModernization yAct
Both yregulations yand yguidance ydocuments yhave ythe yforce yof ylaw. yTrue yor yFalse?
(2:1) y- ycorrect yanswers y-False. yOnly yregulations yhave ythe yforce yof ylaw.
Although yFDA's ystatutory yauthority ydoes ynot yextend yto ythe yoccupational ysafety
yand yhealth yresponsibilities yof yOSHA ythe yagencies ycoordinate ytheir yefforts yin
ymatters yof yrelated yresponsibility ysuch yas yunshielded ysyringes yand ynatural yrubber
ylatex. yTrue yor yFalse?(2:2) y- ycorrect yanswers y-True
An yFDA ypetition ymuch ycontain ywhich yof ythe yfollowing? ya) yAction yrequested yb)
yStatement yof ygrounds yc) yEnvironmental yimpact yd) yAll yof ythe yabove(2:3) y- ycorrect
yanswers y-D: yAll yof ythe yabove
Drugs ymay ybe yeligible yfor yover-the-counter ystatus ywhen: ya) yThey yhave ybeen
ymarketed yto ya ymaterial yextent yb) yThey yhave ybeen ymarketed yfor ya ymaterial ytime
yc) yAre ygenerally yrecognized yas ysafe yd) yAll yof ythe yabove(2:4) y- ycorrect yanswers
y-D: yAll yof ythe yabove
Biologics yare ycleared yfor ymarketing ythrough ywhich yprocess y?a) yEstablishment
yLicense yApplication y(ELA)b) yProduct yLicense yApplication y(PLA)c) yBiologics
yLicense yApplication y(BLA)d) yAll yof ythe yabove(2:5) y- ycorrect yanswers y-C:
yBiologics yLicense yApplication y(BLA)
A ySpecial y510(k) yrelies yon ythe yfollowing yinformation: ya) yDesign ycontrol
ydocumentation yb) yGuidance ydocuments yc) yConsensus ystandards yd) yAll yof ythe
yabove(2:6) y- ycorrect yanswers y-A: yDesign ycontrol ydocumentation
Which yact yrequired yrulemaking ymeetings yto ybe yopen yto ythe ypublic? ya)
yMoonshine yAct yb) yGovernment yin ythe ySunshine yAct yc) yFood yDrug yand
yCosmetics yAct yd) yAdministrative yAmendments yAct(2:7) y- ycorrect yanswers y-B:
yGovernment yin ythe ySunshine yAct
Which yof ythe yfollowing ydoes ynot ydistinguish ythe ydevelopment yof ydrugs yfor yanimal
yuse yfrom ythose yfor yhuman yuse: ya) yThe yability yto yuse yknown ydata yfrom ythe
ydevelopment yof ya ydrug yfor yuse yin yhumans yor yother yanimal yspecies yas
yapplicable. yb) yGenerally ysafety yand yefficacy ystudies yrequire yonly y10s yof yanimals
yper ygroup ycompared yto ythe y100s yof ypatients yper ygroup yrequired yfor yhuman
ydrugs. yc) yDoes ynot yhave yuser yfees yfor yNADAs. yd) ySpecies yclass yand ybreed yof
yanimals yas ywell yas ygeographical ydifferences yare ymore yrelevant.(3:1) y- ycorrect
yanswers y-C: yDoes ynot yhave yuser yfees yfor yNADAs.
, A ygeneric ydrug yis ydeemed ybioequivalent yto ythe yRLD yif yin yclinical ybioequivalence
ystudies ythe y90% yconfidence yintervals yfor ythe yratio yof ypopulation ygeometric
ymeans ybetween ythe ytwo ytreatments ybased yon ylog-transformed ydata yis ycontained
ywithin ythe yequivalence ylimits yof y____% y- y____% yfor yAUC yand yCmax. ya) y80
y120 yb) y75 y125 yc) y90 y110 yd) y80 y125(3:2) y- ycorrect yanswers y-D: y80% yand
y125%
What yis ythe ydefinition yof ya ybiologic?(3:3) y- ycorrect yanswers y-A ysubstance yderived
yfrom yor ymade ywith ythe yaid yof yliving yorganisms.
What yare ythe ymajor ycategories yof yICH yguidelines?(3:4) y- ycorrect yanswers y-Quality
ySafety yEfficacy yMultidisciplinary
What yis ythe ydeadline yfor yan yinitial yIND ySafety yreport yof ya yfatal yor ylife-threatening
yserious yadverse yevent?(3:5) y- ycorrect yanswers y-7 ydays
FDA ypromulgates yregulations yin ywhich yof ythe yfollowing? ya) yCode yof yFederal
yRegulations yb) yDocket yManagement ySystem yc) yFederal yRegister yd) yFederal
yDocket(4:1) y- ycorrect yanswers y-C: yFederal yRegister
What yfive ytypes yof yapplication ymeetings yare yavailable yto ysponsors ysubmitting
ymedical ydevices yto yCDRH?(4:2) y- ycorrect yanswers y-Agreement yDetermination
yPre-IDE yPre-PMA yand yPMA yday-100
Under ywhat ycircumstances yis yit yappropriate yto yrequest ya yType yA ymeeting?(4:3) y-
ycorrect yanswers y-The yType yA ymeeting yis yone ythat yis yimmediately ynecessary yfor
yan yotherwise ystalled ydrug ydevelopment yprogram yto yproceed. yType yA ymeetings
yare yreserved yfor ydispute yresolution ydiscussion yof yclinical yholds yand yspecial
yprotocol yassessment ymeetings.
True yor yFalse: yA yhearing yto yreview ythe ysafety yand yefficacy yof yan yNDC yis ya
ypublic yhearing ybefore ythe ycommissioner. y(4:4) y- ycorrect yanswers y-False. yA
yhearing yto yreview ythe ysafety yand yefficacy yof yan yNDA yis ya ypublic yhearing ybefore
ya ypublic yadvisory ycommittee.
True yor yFalse: yFDA yadvisory ycommittee ymeetings ymay ybe ycompletely yclosed yto
ythe ypublic yand ynotice yof ya ymeeting yis ynot yrequired yto ybe ypublished yuntil ythe
yday yof ythe ymeeting. y(5:1) y- ycorrect yanswers y-False: yAdvisory ycommittee
ymeetings ymay ybe yclosed ybut yno yadvisory ycommittee ymeeting ycan ybe ycompletely
yclosed y(21 yCFR y14.27)
True yor yFalse: yFDA yadvisory ycommittees yprovide yindependent yexpert yadvice yand
ycredibility yto yproduct yreviews. y(5:2) y- ycorrect yanswers y-True
Where ycan yyou yfind yguidance yon ythe ytime yframes yfor ypreparing ybriefing
ymaterials yfor yan yadvisory ycommittee ymeeting?(5:3) y- ycorrect yanswers y-"Guidance
ANSWERS
Which yof ythe yfollowing ywas yNOT ya yrequirement yof ythe yoriginal yFood yDrug yand
yCosmetic yAct yof y1938? ya) yProof yof yefficacy yb) yProof yof ysafety yc) yAuthorized
ystandards yof yidentify yd) ySafe ytolerances yfor yunavoidable ypoisonous
ysubstances(1:1) y- ycorrect yanswers y-A: yProof yof yefficacy
Which yamendments yto ythe yFD&C yAct yresulted yfrom ythe ythalidomide ytragedy? ya)
yDurham-Humphrey yAmendments yb) yHatch-Waxman yAct yc) yControlled ySubstances
yAct yd) yKefauver-Harris yAmendments y(1:2) y- ycorrect yanswers y-D: yKefauver-Harris
yAmendments
The yColor yAdditive yAmendment yof y1960 yrequired yFDA yto yprove ythat ya ycolor
yadditive ywas yunsafe ybefore yremoving yit yfrom ythe ymarket. ya) yTrue yb) yFalse(1:3)
y- ycorrect yanswers y-B: yFalse
,What yhas ybeen ydescribed yas y"the ymost yextensive ychange yto ythe yagency's
ypractices ysince y1938?" ya) yPrescription yDrug yUser yFee yAct yof y1922b) yGMPs yfor
ythe y21st yCentury yinitiative yc) yFood yand yDrug yAdministration yModernization yAct
yd) yFood yand yDrug yAdministration yAmendments yAct(1:4) y- ycorrect yanswers y-C:
yFood yand yDrug yAdministration yModernization yAct
Both yregulations yand yguidance ydocuments yhave ythe yforce yof ylaw. yTrue yor yFalse?
(2:1) y- ycorrect yanswers y-False. yOnly yregulations yhave ythe yforce yof ylaw.
Although yFDA's ystatutory yauthority ydoes ynot yextend yto ythe yoccupational ysafety
yand yhealth yresponsibilities yof yOSHA ythe yagencies ycoordinate ytheir yefforts yin
ymatters yof yrelated yresponsibility ysuch yas yunshielded ysyringes yand ynatural yrubber
ylatex. yTrue yor yFalse?(2:2) y- ycorrect yanswers y-True
An yFDA ypetition ymuch ycontain ywhich yof ythe yfollowing? ya) yAction yrequested yb)
yStatement yof ygrounds yc) yEnvironmental yimpact yd) yAll yof ythe yabove(2:3) y- ycorrect
yanswers y-D: yAll yof ythe yabove
Drugs ymay ybe yeligible yfor yover-the-counter ystatus ywhen: ya) yThey yhave ybeen
ymarketed yto ya ymaterial yextent yb) yThey yhave ybeen ymarketed yfor ya ymaterial ytime
yc) yAre ygenerally yrecognized yas ysafe yd) yAll yof ythe yabove(2:4) y- ycorrect yanswers
y-D: yAll yof ythe yabove
Biologics yare ycleared yfor ymarketing ythrough ywhich yprocess y?a) yEstablishment
yLicense yApplication y(ELA)b) yProduct yLicense yApplication y(PLA)c) yBiologics
yLicense yApplication y(BLA)d) yAll yof ythe yabove(2:5) y- ycorrect yanswers y-C:
yBiologics yLicense yApplication y(BLA)
A ySpecial y510(k) yrelies yon ythe yfollowing yinformation: ya) yDesign ycontrol
ydocumentation yb) yGuidance ydocuments yc) yConsensus ystandards yd) yAll yof ythe
yabove(2:6) y- ycorrect yanswers y-A: yDesign ycontrol ydocumentation
Which yact yrequired yrulemaking ymeetings yto ybe yopen yto ythe ypublic? ya)
yMoonshine yAct yb) yGovernment yin ythe ySunshine yAct yc) yFood yDrug yand
yCosmetics yAct yd) yAdministrative yAmendments yAct(2:7) y- ycorrect yanswers y-B:
yGovernment yin ythe ySunshine yAct
Which yof ythe yfollowing ydoes ynot ydistinguish ythe ydevelopment yof ydrugs yfor yanimal
yuse yfrom ythose yfor yhuman yuse: ya) yThe yability yto yuse yknown ydata yfrom ythe
ydevelopment yof ya ydrug yfor yuse yin yhumans yor yother yanimal yspecies yas
yapplicable. yb) yGenerally ysafety yand yefficacy ystudies yrequire yonly y10s yof yanimals
yper ygroup ycompared yto ythe y100s yof ypatients yper ygroup yrequired yfor yhuman
ydrugs. yc) yDoes ynot yhave yuser yfees yfor yNADAs. yd) ySpecies yclass yand ybreed yof
yanimals yas ywell yas ygeographical ydifferences yare ymore yrelevant.(3:1) y- ycorrect
yanswers y-C: yDoes ynot yhave yuser yfees yfor yNADAs.
, A ygeneric ydrug yis ydeemed ybioequivalent yto ythe yRLD yif yin yclinical ybioequivalence
ystudies ythe y90% yconfidence yintervals yfor ythe yratio yof ypopulation ygeometric
ymeans ybetween ythe ytwo ytreatments ybased yon ylog-transformed ydata yis ycontained
ywithin ythe yequivalence ylimits yof y____% y- y____% yfor yAUC yand yCmax. ya) y80
y120 yb) y75 y125 yc) y90 y110 yd) y80 y125(3:2) y- ycorrect yanswers y-D: y80% yand
y125%
What yis ythe ydefinition yof ya ybiologic?(3:3) y- ycorrect yanswers y-A ysubstance yderived
yfrom yor ymade ywith ythe yaid yof yliving yorganisms.
What yare ythe ymajor ycategories yof yICH yguidelines?(3:4) y- ycorrect yanswers y-Quality
ySafety yEfficacy yMultidisciplinary
What yis ythe ydeadline yfor yan yinitial yIND ySafety yreport yof ya yfatal yor ylife-threatening
yserious yadverse yevent?(3:5) y- ycorrect yanswers y-7 ydays
FDA ypromulgates yregulations yin ywhich yof ythe yfollowing? ya) yCode yof yFederal
yRegulations yb) yDocket yManagement ySystem yc) yFederal yRegister yd) yFederal
yDocket(4:1) y- ycorrect yanswers y-C: yFederal yRegister
What yfive ytypes yof yapplication ymeetings yare yavailable yto ysponsors ysubmitting
ymedical ydevices yto yCDRH?(4:2) y- ycorrect yanswers y-Agreement yDetermination
yPre-IDE yPre-PMA yand yPMA yday-100
Under ywhat ycircumstances yis yit yappropriate yto yrequest ya yType yA ymeeting?(4:3) y-
ycorrect yanswers y-The yType yA ymeeting yis yone ythat yis yimmediately ynecessary yfor
yan yotherwise ystalled ydrug ydevelopment yprogram yto yproceed. yType yA ymeetings
yare yreserved yfor ydispute yresolution ydiscussion yof yclinical yholds yand yspecial
yprotocol yassessment ymeetings.
True yor yFalse: yA yhearing yto yreview ythe ysafety yand yefficacy yof yan yNDC yis ya
ypublic yhearing ybefore ythe ycommissioner. y(4:4) y- ycorrect yanswers y-False. yA
yhearing yto yreview ythe ysafety yand yefficacy yof yan yNDA yis ya ypublic yhearing ybefore
ya ypublic yadvisory ycommittee.
True yor yFalse: yFDA yadvisory ycommittee ymeetings ymay ybe ycompletely yclosed yto
ythe ypublic yand ynotice yof ya ymeeting yis ynot yrequired yto ybe ypublished yuntil ythe
yday yof ythe ymeeting. y(5:1) y- ycorrect yanswers y-False: yAdvisory ycommittee
ymeetings ymay ybe yclosed ybut yno yadvisory ycommittee ymeeting ycan ybe ycompletely
yclosed y(21 yCFR y14.27)
True yor yFalse: yFDA yadvisory ycommittees yprovide yindependent yexpert yadvice yand
ycredibility yto yproduct yreviews. y(5:2) y- ycorrect yanswers y-True
Where ycan yyou yfind yguidance yon ythe ytime yframes yfor ypreparing ybriefing
ymaterials yfor yan yadvisory ycommittee ymeeting?(5:3) y- ycorrect yanswers y-"Guidance
