RAPS Test 6 with correct Answers
Your iicompany iiwould iilike iito iisubmit iian iiIND iifor iia iinew iiinvestigational iidrug's iiuse iion
iisubjects iiwith iia iilife-threatening iidisease iifor iiwhich iino iisuitable iialternative iidrugs iiare
iiavailable. iiWhich iitype iiof iiIND iiapplication iiwould iibe iimost iisuitable iifor iithis iitype iiof
iiinvestigation? ii- iiAnswers ii-Treatment iiIND
A iicompany iiis iiplanning iito iidevelop iia iisunscreen iicontaining iian iiingredient iiconsistent
iiwith iiits iipublished iimonograph iifor iimarketing iiwithin iithe iiUS. iiWhat iitype iiof iifiling
iidoes iithe iicompany iihave iito iisubmit? ii- iiAnswers ii-No iipremarket iiapproval iiis iirequired
To iiobtain iiapproval iifor iian iiANDA, iia iicompany iiMUST iimeet iiwhich iicriterion? ii-
iiAnswers ii-Demonstrate iibioequivalence iibetween iithe iiinnovator iidrug iiand iithe
iiproposed iigeneric iidrug.
Which iiof iithe iifollowing iiis iinot iian iiinvestigator's iiresponsibility ii- iiAnswers ii-submitting
iiunanticipated iiadverse iievent iireports iito iiFDA
A iicompany iiis iideveloping iian iiunapproved iidrug-device iicombination iiproduct iiin iiwhich
iithe iiprimary iimode iiof iiaction iiis iithe iidrug. iiwhat iiapplication iitype iiand iito iiwhich iicenter
iishould iithe iicompany iisubmit iiits iiapplication iifor iimarketing iiapproval? ii- iiAnswers ii-
Submit iia iiNew iiDrug iiApplication iito iiCDER
Both iiGMP iiand iiGLP iiguidelines iirequire iiwhich iiof iithe iifollowing? ii- iiAnswers ii-
Calibration iiand iipreventive iimaintenance iiof iiequipment
An iiFDA iireviewer iicontacts iia iiregulatory iiprofessional iiwith iia iilengthy iilist iiof iiquestions
iiregarding iia iisubmitted ii510(k) iiapplication. iiSome iiof iithe iiinformation iiis iinot iireadily
iiavailable iiand iimay iirequire iiadditional iidata iicollection. iiWhat iiis iithe iiBEST iicourse iiof
iiaction iifor iithe iiregulatory iiprofessional? ii- iiAnswers ii-Send iia iiletter iiwith iianticipated
iiresponse iitime
Blood iiCenter iiABC iihas iijust iiopened iiin iia iiMidwestern iistate. iiIt iiplans iito iimanufacture
iiblood iiand iiblood iiproducts iifrom iivolunteer iiblood iidonors iiand iioffer iithese iiproducts
iifor iisale iito iilocal iidialysis iiclinics iiand iihospitals iiin iiother iistates. iiBlood iiCenter iiABC
iimust: ii- iiAnswers ii-Register iiwith iiFDA iiwithin iifive iidays iiafter iibeginning iioperations
iiand iiprovide iia iicurrent iilist iiof iiall iiproducts iimanufactured, iiprepared iiand iiprocessed
iithat iiare iiin iicommercial iidistribution
A iicompany iiis iideveloping iian ii(unapproved) iidrug-device iicombination iiproduct iibut iiis
iinot iisure iito iiwhich iicenter iiit iishould iisubmit iiits iimarketing iiapplication. iiThe iicompany
, iishould iifirst iisubmit. ii- iiAnswers ii-A iirequest iifor iiDesignation iito iithe iiOffice iiof
iiCombination iiProducts
During iia iireview iiof iithe iiproduction iirecords iifor iiBatch ii1 iiof iiDrug iiProduct iiX, iiit iiwas
iidiscovered iithe iitheoretical iiyield iiexceeded iithe iimaximum iipercentage iiestablished iiin
iithe iimaster iiproduction iiand iicontrol iirecords iiby ii1.5%. iiThe iibatch iihas iinot iibeen
iidistributed. iiAs iia iiregulatory iiprofessional, iiyou iishould iirecommend iithe iiinvestigation:
A. iiBe iiextended iito iionly iiother iibatches iiof iiDrug iiProduct iiX
B. iiBe iiextended iito iiother iidrug iiproducts iithat iimay iihave iibeen iiassociated iiwith iithe
iidiscrepancy
C. iiNo iiimmediate iiaction iiis iineeded iibut iithe iidiscrepancy iishould iibe iinoted iiin iithe
iinext iiAnnual iiReport
D. iiFurther iiproduction iishould iibe iihalted iiuntil iithe iireason iifor iithe iidiscrepancy iiis
iiidentified ii- iiAnswers ii-Be iiextended iito iiother iidrug iiproducts iithat iimay iihave iibeen
iiassociated iiwith iithe iidiscrepancy
A iifirm iireceived iia iiraw iimaterial iifor iione iiof iiits iidrug iiproducts. iiThe iiraw iimaterial iiwas
iiplaced iiin iiquarantine iiand iisampled iiappropriately. iiSample iicontainers iishould iibe
iiidentified iiso iithe iifollowing iiinformation iican iibe iidetermined. ii- iiAnswers ii-The iimaterial
iiname, iilot iinumber, iithe iicontainer iifrom iiwhich iithe iisample iiwas iitaken, iiname iiof
iiperson iiwho iicollected iithe iisample iiand iithe iidate iion iiwhich iithe iisample iiwas iitaken.
The iisupplier iiof iia iiresin iiused iiin iia iicontainer iiof iia iimarketed iidrug iiproduct iiis
iidiscontinuing iiproduction, iiand iithe iicurrent iisupply iiwill iibe iiexhausted iiin iisix iimonths.
iiA iidifferent iiresin iihas iibeen iiidentified iias iia iireplacement. iiWhich iiof iithe iifollowing
iimechanisms iishould iithe iiregulatory iiprofessional iirecommend iito iimaintain
iicompliance? ii- iiAnswers ii-Post-approval iistudies
A iicompany iireceives iiFDA iiapproval iifor iia iimajor iiefficacy iisupplement iito iian iiNDA.
iiThe iiregulatory iiprofessional iishould iiprepare iithe iidrug iisafety iidepartment iifor iiwhich
iiof iithe iifollowing? ii- iiAnswers ii-Potential iifor iimore iifrequent iiperiodic iiadverse iidrug
iiexperience iireports.
Within iihow iimany iidays iiafter iireceipt iiMUST iithe iiFDA iifile, iior iirefuse iito iifile, iiand
iiNDA? ii- iiAnswers ii-60 iidays
A iiregulatory iiprofessional iiis iinegotiating iiwith iithe iiFDA iion iia iiproduct's iifinal iilabeling.
iiThe iicompany's iimanagement iiis iiadamant iiabout iiincluding iia iiclaim iiin iithe iilabeling.
iiWhile iithe iiFDA iiis iiproposing iia iimore iirestrictive iiclaim. iiWhat iiis iithe iiregulatory
iiprofessional's iiBEST iicourse iiof iiaction? ii- iiAnswers ii-Negotiate iiwith iithe iireview
iidivision
What iisource iishould iithe iiregulatory iiprofessional iiconsult iito iidetermine iiwhen iia
iiproduct's iipatent iiand iiexclusivity iiwill iiexpire? ii- iiAnswers ii-The iiOrange iiBook
Your iicompany iiwould iilike iito iisubmit iian iiIND iifor iia iinew iiinvestigational iidrug's iiuse iion
iisubjects iiwith iia iilife-threatening iidisease iifor iiwhich iino iisuitable iialternative iidrugs iiare
iiavailable. iiWhich iitype iiof iiIND iiapplication iiwould iibe iimost iisuitable iifor iithis iitype iiof
iiinvestigation? ii- iiAnswers ii-Treatment iiIND
A iicompany iiis iiplanning iito iidevelop iia iisunscreen iicontaining iian iiingredient iiconsistent
iiwith iiits iipublished iimonograph iifor iimarketing iiwithin iithe iiUS. iiWhat iitype iiof iifiling
iidoes iithe iicompany iihave iito iisubmit? ii- iiAnswers ii-No iipremarket iiapproval iiis iirequired
To iiobtain iiapproval iifor iian iiANDA, iia iicompany iiMUST iimeet iiwhich iicriterion? ii-
iiAnswers ii-Demonstrate iibioequivalence iibetween iithe iiinnovator iidrug iiand iithe
iiproposed iigeneric iidrug.
Which iiof iithe iifollowing iiis iinot iian iiinvestigator's iiresponsibility ii- iiAnswers ii-submitting
iiunanticipated iiadverse iievent iireports iito iiFDA
A iicompany iiis iideveloping iian iiunapproved iidrug-device iicombination iiproduct iiin iiwhich
iithe iiprimary iimode iiof iiaction iiis iithe iidrug. iiwhat iiapplication iitype iiand iito iiwhich iicenter
iishould iithe iicompany iisubmit iiits iiapplication iifor iimarketing iiapproval? ii- iiAnswers ii-
Submit iia iiNew iiDrug iiApplication iito iiCDER
Both iiGMP iiand iiGLP iiguidelines iirequire iiwhich iiof iithe iifollowing? ii- iiAnswers ii-
Calibration iiand iipreventive iimaintenance iiof iiequipment
An iiFDA iireviewer iicontacts iia iiregulatory iiprofessional iiwith iia iilengthy iilist iiof iiquestions
iiregarding iia iisubmitted ii510(k) iiapplication. iiSome iiof iithe iiinformation iiis iinot iireadily
iiavailable iiand iimay iirequire iiadditional iidata iicollection. iiWhat iiis iithe iiBEST iicourse iiof
iiaction iifor iithe iiregulatory iiprofessional? ii- iiAnswers ii-Send iia iiletter iiwith iianticipated
iiresponse iitime
Blood iiCenter iiABC iihas iijust iiopened iiin iia iiMidwestern iistate. iiIt iiplans iito iimanufacture
iiblood iiand iiblood iiproducts iifrom iivolunteer iiblood iidonors iiand iioffer iithese iiproducts
iifor iisale iito iilocal iidialysis iiclinics iiand iihospitals iiin iiother iistates. iiBlood iiCenter iiABC
iimust: ii- iiAnswers ii-Register iiwith iiFDA iiwithin iifive iidays iiafter iibeginning iioperations
iiand iiprovide iia iicurrent iilist iiof iiall iiproducts iimanufactured, iiprepared iiand iiprocessed
iithat iiare iiin iicommercial iidistribution
A iicompany iiis iideveloping iian ii(unapproved) iidrug-device iicombination iiproduct iibut iiis
iinot iisure iito iiwhich iicenter iiit iishould iisubmit iiits iimarketing iiapplication. iiThe iicompany
, iishould iifirst iisubmit. ii- iiAnswers ii-A iirequest iifor iiDesignation iito iithe iiOffice iiof
iiCombination iiProducts
During iia iireview iiof iithe iiproduction iirecords iifor iiBatch ii1 iiof iiDrug iiProduct iiX, iiit iiwas
iidiscovered iithe iitheoretical iiyield iiexceeded iithe iimaximum iipercentage iiestablished iiin
iithe iimaster iiproduction iiand iicontrol iirecords iiby ii1.5%. iiThe iibatch iihas iinot iibeen
iidistributed. iiAs iia iiregulatory iiprofessional, iiyou iishould iirecommend iithe iiinvestigation:
A. iiBe iiextended iito iionly iiother iibatches iiof iiDrug iiProduct iiX
B. iiBe iiextended iito iiother iidrug iiproducts iithat iimay iihave iibeen iiassociated iiwith iithe
iidiscrepancy
C. iiNo iiimmediate iiaction iiis iineeded iibut iithe iidiscrepancy iishould iibe iinoted iiin iithe
iinext iiAnnual iiReport
D. iiFurther iiproduction iishould iibe iihalted iiuntil iithe iireason iifor iithe iidiscrepancy iiis
iiidentified ii- iiAnswers ii-Be iiextended iito iiother iidrug iiproducts iithat iimay iihave iibeen
iiassociated iiwith iithe iidiscrepancy
A iifirm iireceived iia iiraw iimaterial iifor iione iiof iiits iidrug iiproducts. iiThe iiraw iimaterial iiwas
iiplaced iiin iiquarantine iiand iisampled iiappropriately. iiSample iicontainers iishould iibe
iiidentified iiso iithe iifollowing iiinformation iican iibe iidetermined. ii- iiAnswers ii-The iimaterial
iiname, iilot iinumber, iithe iicontainer iifrom iiwhich iithe iisample iiwas iitaken, iiname iiof
iiperson iiwho iicollected iithe iisample iiand iithe iidate iion iiwhich iithe iisample iiwas iitaken.
The iisupplier iiof iia iiresin iiused iiin iia iicontainer iiof iia iimarketed iidrug iiproduct iiis
iidiscontinuing iiproduction, iiand iithe iicurrent iisupply iiwill iibe iiexhausted iiin iisix iimonths.
iiA iidifferent iiresin iihas iibeen iiidentified iias iia iireplacement. iiWhich iiof iithe iifollowing
iimechanisms iishould iithe iiregulatory iiprofessional iirecommend iito iimaintain
iicompliance? ii- iiAnswers ii-Post-approval iistudies
A iicompany iireceives iiFDA iiapproval iifor iia iimajor iiefficacy iisupplement iito iian iiNDA.
iiThe iiregulatory iiprofessional iishould iiprepare iithe iidrug iisafety iidepartment iifor iiwhich
iiof iithe iifollowing? ii- iiAnswers ii-Potential iifor iimore iifrequent iiperiodic iiadverse iidrug
iiexperience iireports.
Within iihow iimany iidays iiafter iireceipt iiMUST iithe iiFDA iifile, iior iirefuse iito iifile, iiand
iiNDA? ii- iiAnswers ii-60 iidays
A iiregulatory iiprofessional iiis iinegotiating iiwith iithe iiFDA iion iia iiproduct's iifinal iilabeling.
iiThe iicompany's iimanagement iiis iiadamant iiabout iiincluding iia iiclaim iiin iithe iilabeling.
iiWhile iithe iiFDA iiis iiproposing iia iimore iirestrictive iiclaim. iiWhat iiis iithe iiregulatory
iiprofessional's iiBEST iicourse iiof iiaction? ii- iiAnswers ii-Negotiate iiwith iithe iireview
iidivision
What iisource iishould iithe iiregulatory iiprofessional iiconsult iito iidetermine iiwhen iia
iiproduct's iipatent iiand iiexclusivity iiwill iiexpire? ii- iiAnswers ii-The iiOrange iiBook
