RAC Test 2 with correct Answers
Requirements iifor iiReserve iiLots iiof iiAPI ii- iiAnswers ii-A iireserve iisample iirepresentative
iiof iieach iilot iiof iieach iishipment iiof iieach iiactive iiingredient iishall iibe iiretained.
2x iithe iiamount iithat iiwould iibe iineeded iifor iithe iitesting iiprotocol iiare iineeded
Reserve iisamples iineed iito iibe iistored iiat iilabeled iiconditions
Any iideterioration iineeds iito iibe iiinvestigated
Special iiControl ii- iiAnswers ii-Black iiBox iiWarning
Treatement iiIND ii- iiAnswers ii-issued iias iia iimeans iiof iiproviding iieligible iisubjects iiwith
iiinvestigational iidrugs iior iibiologics iifor iithe iitreatment iiof iiserious iiand iilife-threatening
iiillnesses iifor iiwhich iithere iiare iino iisuitable iialternative iitreatments. iiRegulatory
iiReference: ii21 iiCFR iiPart ii312.83.
Auditor iiIndependence ii- iiAnswers ii-The iiquality iiassurance iimanager iicannot iiaudit
iiareas iiof iithe iiquality iisystem iifor iiwhich iihe/she iiis iiresponsible. iiRegulatory iiReference:
ii21 iiCFR ii820.22.
ANDA iicannt iibe iiexpidited iibecause: ii- iiAnswers ii-Products iithat iishow iievidence iiof
iisafety iiand iieffectiveness iiin iia iinew iisubpopulation
Orphan iiDrug iiStatus ii- iiAnswers ii-cannot iibe iirequuested iionce iianother iiNDA ii(non-
orphan) iiis iiunder iireivew iifor iithe iisame iiindication.
HDE iiDevice iiApplication ii- iiAnswers ii-is iinot iirequired iito iicontain iithe iiresults iiof
iiscientifically iivalid iiclinical iiinvestigations iidemonstrating iieffectiveness iifor iiits iiintended
iipurpose.
Special iiProtocol iiAssesement ii- iiAnswers ii-Cannot iibe iia iidose iiranging iistudy.
CBER ii- iiAnswers ii-Reviews iiapplications iifor iicombination iiproducts iithat iiare iiboth
iibiologics iiand iidevices ii(interagency iiagreement)
14 iicalendar iidays ii- iiAnswers ii-if iiproduct iiis iiapproved iibased iion iidraft iilabeling, iithe
iicompany iihas iithis iilong iiafter iiapproval iito iisubmit iifinal iilabeling
Direct iiBenefit ii- iiAnswers ii-Clinical iiinvestigations iiinvolving iigreater iithan iiminimal iirisk
iiand iino iiprospect iiof iidirect iibenefit iito iiindividual iisubjects, iibut iilikely iiyield iigeneralized
iiknowledge iiabout iithe iisubjects' iidisorder iior iicondition iimay iibe iiapproved iiso iilong iias
iiall iiother iiregulatory iirequirements iiare iimet.
Requirements iifor iiReserve iiLots iiof iiAPI ii- iiAnswers ii-A iireserve iisample iirepresentative
iiof iieach iilot iiof iieach iishipment iiof iieach iiactive iiingredient iishall iibe iiretained.
2x iithe iiamount iithat iiwould iibe iineeded iifor iithe iitesting iiprotocol iiare iineeded
Reserve iisamples iineed iito iibe iistored iiat iilabeled iiconditions
Any iideterioration iineeds iito iibe iiinvestigated
Special iiControl ii- iiAnswers ii-Black iiBox iiWarning
Treatement iiIND ii- iiAnswers ii-issued iias iia iimeans iiof iiproviding iieligible iisubjects iiwith
iiinvestigational iidrugs iior iibiologics iifor iithe iitreatment iiof iiserious iiand iilife-threatening
iiillnesses iifor iiwhich iithere iiare iino iisuitable iialternative iitreatments. iiRegulatory
iiReference: ii21 iiCFR iiPart ii312.83.
Auditor iiIndependence ii- iiAnswers ii-The iiquality iiassurance iimanager iicannot iiaudit
iiareas iiof iithe iiquality iisystem iifor iiwhich iihe/she iiis iiresponsible. iiRegulatory iiReference:
ii21 iiCFR ii820.22.
ANDA iicannt iibe iiexpidited iibecause: ii- iiAnswers ii-Products iithat iishow iievidence iiof
iisafety iiand iieffectiveness iiin iia iinew iisubpopulation
Orphan iiDrug iiStatus ii- iiAnswers ii-cannot iibe iirequuested iionce iianother iiNDA ii(non-
orphan) iiis iiunder iireivew iifor iithe iisame iiindication.
HDE iiDevice iiApplication ii- iiAnswers ii-is iinot iirequired iito iicontain iithe iiresults iiof
iiscientifically iivalid iiclinical iiinvestigations iidemonstrating iieffectiveness iifor iiits iiintended
iipurpose.
Special iiProtocol iiAssesement ii- iiAnswers ii-Cannot iibe iia iidose iiranging iistudy.
CBER ii- iiAnswers ii-Reviews iiapplications iifor iicombination iiproducts iithat iiare iiboth
iibiologics iiand iidevices ii(interagency iiagreement)
14 iicalendar iidays ii- iiAnswers ii-if iiproduct iiis iiapproved iibased iion iidraft iilabeling, iithe
iicompany iihas iithis iilong iiafter iiapproval iito iisubmit iifinal iilabeling
Direct iiBenefit ii- iiAnswers ii-Clinical iiinvestigations iiinvolving iigreater iithan iiminimal iirisk
iiand iino iiprospect iiof iidirect iibenefit iito iiindividual iisubjects, iibut iilikely iiyield iigeneralized
iiknowledge iiabout iithe iisubjects' iidisorder iior iicondition iimay iibe iiapproved iiso iilong iias
iiall iiother iiregulatory iirequirements iiare iimet.
