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RAC Exam - Devices US Questions and Answers
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RAC Exam - Devices US Questions and Answers
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RAC Exam - Devices US Questions andAnswers
Regulations ii- iiAnswers ii-interpret iilaws iiand iidescribe iihow iithey iiwill iibe iienforced
guidance iidocument ii- iiAnswers ii-used iito iiconvey iiFDA's iicurrent iithinking iior
iienforcement iipriorities ii- iinot iilegally iibinding
Sherley iiAmendment ii- iiAnswers ii-prohibited iilabeling iimedicines iiwith iifalse iitherapeutic
iiclaims iiintended iito iidefraud iithe iipurchaser
Pure iiFood iiand iiDrug iiAct iiof ii1906 ii- iiAnswers ii-prohibited iimisbranded iiand
iiadulterated iifoods, iidrinks iiand iidrugs iifrom iientering iiinterstate iicommerce
FD&C iiAct ii- iiAnswers ii-1938 ii- iirepealed ii1906 iilaw iiand iisherley iiamendment ii-
iimanufacturers iiwere iirequired iito iiprovide iiscientific iiproof iinew iidrugs iiwere iisafe iifor
iitheir iiintended iiuse iibefore iibeing iiplaced iion iithe iimarket; iicosmetics iiand iimedical
iidevices iiregulated; iiprohibited iiadding iipoisonous iisubstances iito iifood iiunless
iiunavoidable iior iirequired iiin iiproduction; iiFDA iigiven iiauthority iito iibring iifederal iicourt
iiinjunctions, iiproduct iiseizures, iiand iicriminal iiprosecutions
Public iiHealth iiService iiAct iiof ii1944 ii- iiAnswers ii-gave iiFDA iiauthority iiover iibiological
iiproducts ii(vaccines iiand iiserums)
Durham-Humphrey iiAmendment iiof ii1951 ii- iiAnswers ii-clarified iiwhat iiconstituted iia
iiprescription iivs iiover iithe iicounter iidrug ii- iirequired ii"Caution" iistatement
Food iiAdditives iiAmendment iiof ii1958 ii- iiAnswers ii-established iicriteria iifor iifood iito iibe
iiconsidered iiadulterated, iimislabeled iior iiharmful
Kefauver-Harris iiAmendment iiof ii1962 ii- iiAnswers ii-requires iiproof iiof iisafety iiand
iiefficacy iibefore iia iidrug iican iibe iimarketed iiin iithe iiUS
Medical iiDevice iiAmendments iiof ii1976 ii- iiAnswers ii-established iithree iiclasses iiof
iimedical iidevices iibased iion iithe iinecessary iidegree iiof iicontrol iito iiensure iisafety iiand
iiefficacy, iieach iirequiring iia iidifferent iilevel iiof iiregulatory iiscrutiny; iialso iimade
iiprovisions iifor iiER&L iiand iiGMP
Orphan iiDrug iiAct iiof ii1983 ii- iiAnswers ii-provided ii7 iiyears iiof iimarket iiexclusivity iiand
iiincentives iifor iidevelopment iiof iiorphan iidrugs iifor iirare iidiseases
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