RAPS RAC (DRUG) PRACTICE TEST
WITH ACCURATE SOLUTIONS
Which hof hthe hfollowing his hNOT ha hreason hto hfile han hOMOR? h- hcorrect hanswers
h-Switch ha hproduct hfrom hprescription hto hover-the-counter.
You hare ha hmanufacturer hin hthe hUS, hand hyou hdiscover hthat hyour hcompany's htop
hselling hproduct hin hthe hlast htwo hyears hhas hbeen hused hoff-label. hThe hoff-label
huse his hestimated hto hbe habout h70%, hand hit hhas hbeen hconsistent hsince hthe
hproduct hwas hfirst hreleased hto hthe hmarket. hWhich hof hthe hfollowing his hthe hMOST
happropriate hnext hstep? h- hcorrect hanswers h-Discuss hwith hregulatory hauthorities hto
hinvestigate hhow hto hhave hthe hoff-label hindication happroved.
A hpharmaceutical hcompany his hdeveloping ha hnew hdrug. hWhich hof hthe hfollowing
hscenarios hwould hmost hlikely hrequire hextensive hsafety hpharmacology hstudies? h-
hcorrect hanswers h-It his ha hbiotechnology-derived hproduct hthat hrepresents ha hnovel
htherapeutic hclass.
, A hfirm his hpreparing ha h510(k), hpremarket hnotification hto hFDA hfor han hin hvitro
hdiagnostic htest, ha hmicrohematocrit hanalyzer hthat, hamong hother hintended huses,
hcan hdetermine ha hblood hdonor's hhematocrit hprior hto hdonation. hThe hfirm hshould
haddress hthe h510(k) hsubmission hto: h- hcorrect hanswers h-CBER
In hthe hEU, hwhich htype hof hdocumentation hshould hNOT hbe hincluded hin hModule h1
hof ha hsubmitted hdossier? h- hcorrect hanswers h-Quality hOverall hSummary
Blood hCenter hABC hhas hjust hopened hin ha hMidwestern hstate. hIt hplans hto
hmanufacture hblood hand hblood hproducts hfrom hvolunteer hblood hdonors hand hoffer
hthese hproducts hfor hsale hto hlocal hdialysis hclinics hand hhospitals hin hother hstates.
hBlood hCenter hABC hmust: h- hcorrect hanswers h-Register hwith hFDA hwithin hfive
hdays hafter hbeginning hoperations hand hprovide ha hcurrent hlist hof hall hproducts
hmanufactured, hprepared hand hprocessed hthat hare hin hcommercial hdistribution.
FDA hCDER hencourages hsubmission hof ha hhuman hfactor's hvalidation hprotocol hfor
hreview hprior hto hthe hexecution hof hthe hstudy. hWhat his hthe hmost happropriate
hmechanism hby hwhich ha hsponsor hshould huse hto hget hFDA's hfeedback hon hthe
hprotocol? h- hcorrect hanswers h-Submit hthe hprotocol hto hthe hIND.
Investigational hcombination hproducts hthat hinclude ha hdevice hconstituent hpart hare
hsubject hto hwhich hprovision hof h21 hCFR hpart h820? h- hcorrect hanswers h-Design
hControls h(21 hCFR h820.30) hunless hthe hdevice hconstituent hpart his hexempt hfrom
hdesign hcontrols.
Which hU.S. hagency hmakes hthe hfirst hassessment hof ha hnew hdrug's hpotential hfor
haddiction hand/or habuse? h- hcorrect hanswers h-FDA
Which hof hthe hfollowing hstatements habout hbiosimilars his hNOT hcorrect? h- hcorrect
hanswers h-Biosimilars hare hconsidered has hgeneric hpharmaceuticals hand huse hthe
hsame hmarketing hreview hprocedures.
Your hengineering hdepartment hwould hlike hto hinstall ha hdifferent hmixer hfor huse hin
hsolid hdosage hforms, hand hvalidate hit hfor hinterchangeable huse hwith han hexisting
hmixer. hChanging hbetween hwhich hof hthe hfollowing hpairs hof hblenders hwould hbe
hconsidered hthe hleast hlikely hto himpact hproduct hquality? h- hcorrect hanswers h-
Double hcone hblender hand hbin hblender
Which hof hthe hfollowing his hthe hpurpose hof han hend-of-Phase h2 hmeeting hbetween
hthe hIND hsponsor hand hthe hFDA? h- hcorrect hanswers h-To hevaluate hthe hpivotal
hstudy hdesign.
A hregulatory hprofessional his hnegotiating hwith hthe hFDA hon ha hproduct's hfinal
hlabeling. hThe hcompany's hmanagement his hadamant habout hincluding ha hclaim hin
hthe hlabeling, hwhile hthe hFDA his hproposing ha hmore hrestrictive hclaim. hWhat his hthe
WITH ACCURATE SOLUTIONS
Which hof hthe hfollowing his hNOT ha hreason hto hfile han hOMOR? h- hcorrect hanswers
h-Switch ha hproduct hfrom hprescription hto hover-the-counter.
You hare ha hmanufacturer hin hthe hUS, hand hyou hdiscover hthat hyour hcompany's htop
hselling hproduct hin hthe hlast htwo hyears hhas hbeen hused hoff-label. hThe hoff-label
huse his hestimated hto hbe habout h70%, hand hit hhas hbeen hconsistent hsince hthe
hproduct hwas hfirst hreleased hto hthe hmarket. hWhich hof hthe hfollowing his hthe hMOST
happropriate hnext hstep? h- hcorrect hanswers h-Discuss hwith hregulatory hauthorities hto
hinvestigate hhow hto hhave hthe hoff-label hindication happroved.
A hpharmaceutical hcompany his hdeveloping ha hnew hdrug. hWhich hof hthe hfollowing
hscenarios hwould hmost hlikely hrequire hextensive hsafety hpharmacology hstudies? h-
hcorrect hanswers h-It his ha hbiotechnology-derived hproduct hthat hrepresents ha hnovel
htherapeutic hclass.
, A hfirm his hpreparing ha h510(k), hpremarket hnotification hto hFDA hfor han hin hvitro
hdiagnostic htest, ha hmicrohematocrit hanalyzer hthat, hamong hother hintended huses,
hcan hdetermine ha hblood hdonor's hhematocrit hprior hto hdonation. hThe hfirm hshould
haddress hthe h510(k) hsubmission hto: h- hcorrect hanswers h-CBER
In hthe hEU, hwhich htype hof hdocumentation hshould hNOT hbe hincluded hin hModule h1
hof ha hsubmitted hdossier? h- hcorrect hanswers h-Quality hOverall hSummary
Blood hCenter hABC hhas hjust hopened hin ha hMidwestern hstate. hIt hplans hto
hmanufacture hblood hand hblood hproducts hfrom hvolunteer hblood hdonors hand hoffer
hthese hproducts hfor hsale hto hlocal hdialysis hclinics hand hhospitals hin hother hstates.
hBlood hCenter hABC hmust: h- hcorrect hanswers h-Register hwith hFDA hwithin hfive
hdays hafter hbeginning hoperations hand hprovide ha hcurrent hlist hof hall hproducts
hmanufactured, hprepared hand hprocessed hthat hare hin hcommercial hdistribution.
FDA hCDER hencourages hsubmission hof ha hhuman hfactor's hvalidation hprotocol hfor
hreview hprior hto hthe hexecution hof hthe hstudy. hWhat his hthe hmost happropriate
hmechanism hby hwhich ha hsponsor hshould huse hto hget hFDA's hfeedback hon hthe
hprotocol? h- hcorrect hanswers h-Submit hthe hprotocol hto hthe hIND.
Investigational hcombination hproducts hthat hinclude ha hdevice hconstituent hpart hare
hsubject hto hwhich hprovision hof h21 hCFR hpart h820? h- hcorrect hanswers h-Design
hControls h(21 hCFR h820.30) hunless hthe hdevice hconstituent hpart his hexempt hfrom
hdesign hcontrols.
Which hU.S. hagency hmakes hthe hfirst hassessment hof ha hnew hdrug's hpotential hfor
haddiction hand/or habuse? h- hcorrect hanswers h-FDA
Which hof hthe hfollowing hstatements habout hbiosimilars his hNOT hcorrect? h- hcorrect
hanswers h-Biosimilars hare hconsidered has hgeneric hpharmaceuticals hand huse hthe
hsame hmarketing hreview hprocedures.
Your hengineering hdepartment hwould hlike hto hinstall ha hdifferent hmixer hfor huse hin
hsolid hdosage hforms, hand hvalidate hit hfor hinterchangeable huse hwith han hexisting
hmixer. hChanging hbetween hwhich hof hthe hfollowing hpairs hof hblenders hwould hbe
hconsidered hthe hleast hlikely hto himpact hproduct hquality? h- hcorrect hanswers h-
Double hcone hblender hand hbin hblender
Which hof hthe hfollowing his hthe hpurpose hof han hend-of-Phase h2 hmeeting hbetween
hthe hIND hsponsor hand hthe hFDA? h- hcorrect hanswers h-To hevaluate hthe hpivotal
hstudy hdesign.
A hregulatory hprofessional his hnegotiating hwith hthe hFDA hon ha hproduct's hfinal
hlabeling. hThe hcompany's hmanagement his hadamant habout hincluding ha hclaim hin
hthe hlabeling, hwhile hthe hFDA his hproposing ha hmore hrestrictive hclaim. hWhat his hthe
