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Oberon-s RAC Drugs Exam Questions and Answers (Graded A)
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Oberon-s RAC Drugs Exam Questions and Answers
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Oberon's RAC Drugs Exam Questionsand Answers
TEA iiprocess ii- iiAnswers ii-21 iiCFR ii330-14
add iiestablished iiingredient iito iiexisting iiOTC iimonograph
Request iifor iiDesignation ii(RFD) ii- iiAnswers ii-ask iiFDA iiif iiit iiis iia iidrug, iibiological,
iidevice, iicombo
HDE iihumanitarian iidevice iiexcempt ii- iiAnswers ii-no iieffectiveness iidata iirequired
misbranded iidevice ii- iiAnswers ii-not iicleared iithrough ii510k iiprocess ii(but iineeds iione)
adultered iidevice ii- iiAnswers ii-does iinot iihave iiPMA iibut iineeds iione
design iiinput iifor iidevice ii- iiAnswers ii-requirements iithat iimust iibe iimet
IDE ii(Investigational iiDevice iiExemption) ii- iiAnswers ii-report iiwithin ii5 iiworking iidays:
iiemergencies, iiuse iiwithout iiinformed iiconsent, iiIRB iiwithdrawal/approval
unanticipated iievents: ii10 iiworking iidays
Class iiII iiDevice ii- iiAnswers ii-Requires ii510(k).
Substantial iiequivalence iito iialready iimarketed iidevice.
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. iimay iirequire iiclinical iitrials.
Class iiIII iiDevices ii- iiAnswers ii-require iiPMA ii(pre-market iiapproval). iiFDA iihas ii180
iidays iito iiaccept/reject iiapplication
QSR ii- iiAnswers ii-Quality iiSystem iiRegulation ii(21 iiCFR ii820). iiIdentifies iiGMPs iifor
iimedical iidevices.
device iipost-market iireporting ii- iiAnswers ii-serious iievents: ii30 iidays.
public iihealth iirisk: ii5 iidays.
kinds iiof ii510(k) ii- iiAnswers ii-special ii(your iiown iidevice iimodifications, ii30 iiday iireview
iitime)
abbreviated ii(conforms iito iirecognized iistandard, ii15 iidays iireview iitime)
,traditional ii(90 iidays iireview iitime)
PMA iitypes ii- iiAnswers ii-traditional ii
modules
(alternative: iiPDP iiproduct iidevelopment iiprotocol)
180 iiday iisupplement ii(device) ii- iiAnswers ii-supplement iito iian iiapproved iipremarket
iiapplication iithat iirequests iisignificant iichanges
abbreviated ii501k ii- iiAnswers ii-special iicontrols iiexist
special ii501k ii- iiAnswers ii-device iiis iiunder ii510k iialready, iiminor iimodifications iido iinot
iiaffect iiuse
OTC iimonograph iiamendments ii- iiAnswers ii-TEA, iicitizen's iipetition
FDAMA ii1997 ii- iiAnswers ii-orphan iidrug iiexempt iifrom iifees ii(can iiseek iiwaiver)
fees iifor iiIND iiphase iibiosimilars ii- iiAnswers ii-Biosimilar iiUser iiFee iiAct ii2012
FDA ii- iipublic iiproceedings ii- iiAnswers ii-5 iitypes:
advisory iicommittee iimeeting
public iiregulatory iihearing ii(by iicommissioner)
public iiworkshop
board iiof iiinquiry
evidentiary iihearing
Public iiRegulatory iiHearing ii- iiAnswers ii-21 iiCFR16
by iicommissioner, iidetermines iiPMA/IRB iidisqualification
Fast iiTrack iiReview ii- iiAnswers ii-unmet iimedical iineeds
rolling iireview
FDAMA ii1997
Priority iiReview ii- iiAnswers ii-FDA iito iitake iiaction iiwithin ii6 iimonths
neglected, iirare iipediatric iidiseases
PDUFA ii1992
no iiclinical iidata iirequired
breakthrough ii- iiAnswers ii-clinical iievidence iishowing iibetter iithan iiwhat iiis iiavailable
QIDP iidesignation ii- iiAnswers ii-fast-track, ii5 iiyears iiexclusivity
(qualified iiinfectious iidisease iiproduct)
,suitability iipetition ii- iiAnswers ii-ANDA ii- iiproduct iiis iidifferent iifrom iiapproved iidrug ii(90
iidays)
citizen's iipetition ii- iiAnswers ii-ANDA ii- iiasking iiFDA iito iirefrain iifrom iicertain iiregulations
ii(180 iidays)
(action iirequested, iienvironmental iiimpact, iistatement iiof iigrounds, iieconomic iiimpact,
iicertification)
CDRH iimeetings ii- iiAnswers ii-presubmission, iiearly iicollaboration, iisubmission iiissue
ii(discuss iideficiencies), iiPMA iiday ii100 ii(review iistatus)
FDA iitype iiA iimeeting ii- iiAnswers ii-"critical iipath iimeeting", iistalled iiprogram, ii30 iidays
iiof iiFDA iireceipt iiof iiwritten iirequest ii+ iireceipt iiof iipackage
FDA iitype iiB iimeeting ii- iiAnswers ii-60 iidays iiafter iirequest
FDA iitype iiC iimeeting ii- iiAnswers ii-75 iidays iiafter iirequest
PMA ii- iiAnswers ii-pre-market iiapproval ii(device)
adverse iievent iiduring iiIND ii- iiAnswers ii-report iiwithin ii7 iidays
quality iisystem iidoes iinot iiinclude ii- iiAnswers ii-test+ iiarticle iicharacterization ii(GLP)
Directive ii2001/83/EC ii- iiAnswers ii-medical iiproducts iifor iihuman iiuse
Directive ii2001/20/EC ii- iiAnswers ii-clinical iitrials
Regulation iiEC ii726/2004 ii- iiAnswers ii-centralized iiauthorization iiprocedure, iiEMA
iiestablished
article ii58 iiapplications ii- iiAnswers ii-medicine iiis iiused iiextensively iioutside iiEU
Regulation iiEC ii141/2000 ii- iiAnswers ii-orphan iidrugs ii(10 iiyears iimarket iiexclusivity)
CEC ii- iiAnswers ii-central iiethics iicommittee ii(EU)
adverse iievents ii(EU) iireporting ii- iiAnswers ii-fatal/serious: iireport iiwithin ii7 iidays,
iiwritten iireport iiwithin ii8 iiadditional iidays
neither iifatal iinor iiserious: iiwithin ii15 iidays
periodic iireporting iibefore iiproduct iiis iimarketed ii(EU) ii- iiAnswers ii-DSUR ii(drug iisafety
iiupdate iireports)
periodic iireporting iifor iidrugs iiunder iidevelopment/ iiunder iistudy iiamong iiICH iiregions
, annually, iican iitake iiplace iiof iiannual iireport ii(annual iiIND iireport iiin iiUS, iiannual iisafety
iireport iiin iiEU)
postmarketing iireports ii(EU) ii- iiAnswers ii-PSUR ii(postmarketing iiperiodic iisafety iiupdate
iireports)
report iion iiworldwide iisafety iiof iimarketed iiproduct
submitted iias iipart iiof iirenewal iiapplication iiwithin ii60 iidays iiof iidata iilock iipoint,
iisubmitted iito iiall iimember iistates, iiEMA iiand iirapporteurs
advertising ii- iiAnswers ii-21CFR ii202
label ii- iiAnswers ii-21 iiCFR ii201
promotion iienforcements iiby iiFDA ii- iiAnswers ii-notice iiof iiviolation ii("untitled iiletters"):
iistop iiusing iimaterial
warning iiletters iito iiCEO
IRB ii- iiAnswers ii-at iileast ii5 iimembers, iivarying iibackground ii& iidiversity, iione iiscientific
iione iinon-scientific, iione iinot iiaffiliated iiwith iiinstitution
pediatric iiexclusivity ii- iiAnswers ii-+ ii6 iimonths ii(FDASIA ii2012)
must iiapply ii9 iimonths iibefore iiexpiration
DMF iitypes ii- iiAnswers ii-type iiI: iimanufacturing, iiprocedure, iifacilities ii(not iiavailable
iianymore)
type iiII: iidrug ii(drug iisubstance, iiintermediate, iimaterial iiused)
type iiIII: iipackaging
type iiIV: iiexcipient
type iiV: iiFDA-accepted iireference
preclinical iitox iireports iito iiFDA iiwhen? ii- iiAnswers ii-120 iidays iiafter iistart iiof iihuman
iistudy
ADE ii(adverse iidrug iievent) iireport ii- iiAnswers ii-within ii15 iidays ii(hospitalized)
PADER ii- iiAnswers ii-post-marketing iiperiodic iisafety iireport
quarterly iiin iifirst ii3 iiyears, iithen iiannually
GDUFA iiII ii2018 ii- iiAnswers ii-generic iidrug iiuser iifee iiact ii(within iiFDASIA). iiapproval
iitime iifor iiANDA: ii10 iimonths
new iidrug iitesting iiphase ii- iiAnswers ii-from iiIND iiapplication iito iiNDA iisubmission
new iidrug iireview iiphase ii- iiAnswers ii-from iiNDA iisubmission iito iiapproval
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