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US RAC Exam Prep Questions and Answers
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US RAC Exam Prep Questions and Answers
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US RAC Exam Prep Questions andAnswers
30-day iihold ii- iiAnswers ii-Time iiframe iibetween iifiling iia iiprotocol iiunder iian iiIND iiand
iithe iiFDA iiapproval iito iiproceed iiwith iienrollment. iiAlso, iithe iitime iiperiod iibetween iiwhen
iia iicompany iisubmits iian iiIND iiand iiwhen iiit iican iiinitiate iia iiprotocol. iiThis iitimeline iimay
iibe iiextended iiif iiFDA iidoes iinot iiagree iiwith iithe iiproposed iiprotocol. ii(see ii"Clinical
iiHold.")
120-day iiSafety iiReport ii- iiAnswers ii-Amendment iito iian iiNDA iicontaining iia iisafety
iiupdate iidue iixx iidays iiafter iithe iiNDA iiis iifiled.
180-day iiExclusivity ii- iiAnswers ii-Protects iian iiANDA iiapplicant iifrom iicompetition iifrom
iisubsequent iigeneric iiversions iiof iithe iisame iidrug iifor iihow iimany iidays?
505(b)(2) iiApplication ii- iiAnswers ii-An iiapplication iisubmitted iiunder iiwhat iisection iiof
iithe iiFD&C iiAct iifor iia iidrug iifor iiwhich iione iior iimore iiof iithe iiinvestigations iirelied iion iiby
iithe iiapplicant iifor iiapproval iiof iithe ii"application iiwere iinot iiconducted iiby iior iifor iithe
iiapplicant iiand iifor iiwhich iithe iiapplicant iihas iinot iiobtained iia iiright iiof iireference iior iiuse
iifrom iithe iiperson iiby iior iifor iiwhom iithe iiinvestigations iiwere iiconducted" ii(21 iiU.S.C.
ii355(b)(2)).
Traditional ii510(k) ii- iiAnswers ii-A iipremarket iinotification ii(PMN) iisubmitted iito iiFDA iito
iidemonstrate iithat iithe iimedical iidevice iito iibe iimarketed iiis iisafe iiand iieffective iior
ii"substantially iiequivalent" iito iia iilegally iimarketed iidevice. ii510(k) iirefers iito iithe iisection
iiof iithe iiFD&C iiAct iiauthorizing iithe iisubmission iiof iithe iipremarket iinotification. iiFDA
iiprocessing iitime iiis ii90 iidays.
Special ii510(k) ii- iiAnswers ii-For iiuse iiwhere iidevice iimodifications iineither iiaffect iithe
iiintended iiuse iinor iialter iiits iifundamental iiscientific iitechnology. iiFDA iiprocessing iitime
iiis ii30 iidays.
Abbreviated ii510(k) ii- iiAnswers ii-A iitype iiof ii510(k) iisubmission iithat iiis iisupported iiby
iiconformance iiwith iiguidance iidocument(s), iispecial iicontrols iior iistandards. iiFDA
iiprocessing iitime iiis ii90 iidays.
515 iiProgram iiInitiative ii- iiAnswers ii-Created iito iifacilitate iireclassification iiaction iion iithe
iiremaining iipre-amendments iiClass iiIII ii510(k)s.
,Accelerated iiApproval ii- iiAnswers ii-Allows iiearlier iiapproval iiof iidrugs iito iitreat iiserious
iidiseases iiand iithose iithat iifill iian iiunmet iimedical iineed iibased iion iia iisurrogate
iiendpoint.
Action iiLetter ii- iiAnswers ii-Official iicommunication iifrom iiFDA iiinforming iian iiNDA iior
iiBLA iisponsor iiof iian iiagency iidecision; iiincludes iiapprovable, iinot iiapprovable iiand
iiclinical iihold.
ADME ii- iiAnswers ii-Absorption, iiDistribution, iiMetabolism iiand iiExcretion
Adulterated ii- iiAnswers ii-Product iicontaining iiany iifilthy, iiputrid iior iidecomposed
iisubstance; iior iiprepared iiunder iiunsanitary iiconditions; iior iinot iimade iiaccording iito
iiGMPs; iior iicontaining iian iiunsafe iicolor iiadditive; iior iidoes iinot iimeet iithe iirequirements
iiof iian iiofficial iicompendium ii(FD&C iiAct, iiSEC. ii501 ii[351])
Advisory iiCommittee ii- iiAnswers ii-Committees iiand iipanels iiused iiby iiFDA iito iiobtain
iiindependent iiexpert iiadvice iion iiscientific, iitechnical iiand iipolicy iimatters.
ANDA ii- iiAnswers ii-Type iiof iiapplication iiused iifor iigeneric iidrugs. iiFound iiin ii21 iiCFR
ii314.92 iiand ii505(j) iiof iithe iiFD&C iiAct. iiAre iinot iirequired iito iiinclude iianimal iisafety iiand
iiclinical iidata iito iidemonstrate iisafety iiand iiefficacy, iibut iifor iioral iidosages iiforms iimust
iiscientifically iidemonstrate iithat iithe iidrug iiis iibioequivalent iito iithe iiReference iiListed
iiDrug ii(RLD). iiCMC ii(Chemistry, iiManufacturing iiand iiControls) iiis iirequired.
Annual iiReport ii- iiAnswers ii-A iitype iiof iireport iithat iimust iibe iisubmitted iito iiFDA
iiregularly. iiDepending iion iithe iitype iiof iiapplication iifor iiwhich iithe iireport iiis iisubmitted,
iiit iimay iiinclude iinew iisafety, iiefficacy iiand iilabeling iiinformation; iipreclinical iiand iiclinical
iiinvestigation iisummaries; iiCMC iiupdates; iinonclinical iilaboratory iistudies; iiand
iicompleted iiunpublished iiclinical iitrials
Approved ii- iiAnswers ii-FDA iidesignation iigiven iito iidrugs, iibiologics iiand iimedical
iidevices iithat iihave iibeen iigranted iimarketing iiapproval
Banned iiDevice ii- iiAnswers ii-Device iipresenting iia iisubstantial iideception,
iiunreasonable iirisk iior iiinjury iior iiillness, iior iiunreasonable iidirect iisubstantial iidanger iito
iipublic iihealth.
BIMO ii- iiAnswers ii-Bioresearch iiMonitoring iiProgram
Bioequivalence ii- iiAnswers ii-The iiabsence iiof iia iisignificant iidifference iiin iithe iirate iiand
iiextent iito iiwhich iithe iiactive iiingredient iior iiactive iimoiety iiin iipharmaceutical
iiequivalents iior iipharmaceutical iialternatives iibecomes iiavailable iiat iithe iisite iiof iidrug
iiaction iiwhen iiadministered iiat iithe iisame iimolar iidose iiunder iisimilar iiconditions iiin iian
iiappropriately iidesigned iistudy.
, Biologic ii- iiAnswers ii-A iivirus, iitherapeutic iiserum, iitoxin, iiantitoxin, iivaccine, iiblood,
iiblood iicomponent iior iiderivative, iiallergenic iiproduct, iiprotein ii(except iiany iichemically
iisynthesized iipolypeptide), iior iianalogous iiproduct, iior iiarsphenamine iior iiderivative iiof
iiarsphenamine ii(or iiany iiother iitrivalent iiorganic iiarsenic iicompound) iiapplicable iito iithe
iiprevention, iitreatment iior iicure iiof iidisease iior iicondition iiof iihuman iibeings.
Biosimilar ii- iiAnswers ii-Under iithe iiBPCI iiAct ii(Biologics iiPrice iiCompetition iiand
iiInnovation iiAct iiof ii2009), iia iibiological iiproduct iimay iibe iidemonstrated iito iibe
ii"biosimilar" iiif iidata iishow iithat, iiamong iiother iithings, iithe iiproduct iiis ii"highly iisimilar" iito
iian iialready iiapproved iibiological iiproduct.
BLA ii- iiAnswers ii-Biologics iiLicense iiApplication
CBE-30 ii- iiAnswers ii-Changes iiBeing iiEffected iiin ii30 iidays. iiA iisubmission iito iian
iiapproved iiapplication iireporting iichanges iithe iiFDA iihas iiidentified iias iihaving
iimoderate iipotential iito iiadversely iiaffect iidrug iiproduct iiidentity, iistrength, iiquality, iipurity
iiand iipotency. iiThe iisupplement iimust iibe iireceived iiby iiFDA iiat iileast ii30 iidays iibefore
iiproduct iidistribution.
CBER ii- iiAnswers ii-Center iifor iiBiologics iiEvaluation iiand iiResearch
CDER ii- iiAnswers ii-Center iifor iiDrug iiEvaluation iiand iiResearch
CDRH ii- iiAnswers ii-Center iifor iiDevices iiand iiRadiological iiHealth
Consent iiForm ii(CF iior iiICF) ii- iiAnswers ii-Document iiused iito iiinform iia iipotential
iisubject iiof iithe iirisks iiand iibenefits iiof iia iiclinical iitrial iiper iithe iiDeclaration iiof iiHelsinki.
Certificate iito iiForeign iiGovernment ii(CFG) ii- iiAnswers ii-Required iiby iicertain iicountries
iito iiprove iithat iian iiexported iiproduct iican iibe iilegally iimarketed iiin iithe iiUS.
CFR ii- iiAnswers ii-Code iiof iiFederal iiRegulations
Class iiI iiDevice ii- iiAnswers ii-Low-risk iidevice iirequiring iigeneral iicontrols iito iiensure
iisafety iiand iieffectiveness.
Class iiII iiDevice ii- iiAnswers ii-Requires iigeneral iiand iispecial iicontrols iito iiensure iisafety
iiand iieffectiveness. iiSpecial iicontrols iimay iiinclude iimandatory iiperformance iistandards,
iipatient iiregistries iifor iiimplantable iidevices iiand iipostmarket iisurveillance. iiRequires
ii510(k), iiunless iiexempted; iimay iirequire iiclinical iitrials.
Class iiIII iiDevice ii- iiAnswers ii-Requires iigeneral iicontrols, iispecial iicontrols iiand
iipremarket iiapproval ii(PMA); iiincludes iidevices iithat iiare iilife-sustaining, iilife-supporting
iior iipose iisignificant iipotential iifor iirisk iito iipatient, iior iiare iinot iisubstantially iiequivalent
iito iiClass iiI iior iiClass iiII iidevices. iiPMAs iialmost iialways iirequire iiclinical iitrials.
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