//////////////////////////////////////////////////////////////////
RAC /
Exam practice questions with correct answers
/ // // // // //
Which /
/of /
/the /
/following /
/was /
/NOT //
a/
/requirement /
/of /
/the /
/original //Food //Drug //and //Cosmetic //Act //of //1938? //a) //Proof //of //efficacy //b) //Proof //of //safety //c)
//Authorized /
/standards /
/of /
/identify /
/d) //Safe //tolerances //for //unavoidable //poisonous //substances(1:1) //- //verified //answer(s)-
✔✔A: //Proof //of //efficacy
Which /
/amendments //to //the //FD&C //Act //resulted //from //the //thalidomide //tragedy? //a) //Durham-
Humphrey //Amendments //b) //Hatch-Waxman //Act //c) //Controlled //Substances //Act //d) //Kefauver-
Harris //Amendments //(1:2) //- //verified //answer(s)-✔✔D: //Kefauver-Harris //Amendments
The /
/Color /
/Additive /
/Amendment /
/of /
/1960 /
/required /
,//////////////////////////////////////////////////////////////////
/FDA /
/to /
/prove /
/that //
a/
/color /
/additive /
/was /
/unsafe //before //removing //it //from //the //market. //a) //True //b) //False(1:3) //- //verified //answer(s)-
✔✔B: //False
What //has //been //described //as //"the //most //extensive //change //to //the //agency's //practices //since
//1938?" /
/a) /
/Prescription /
/Drug /
/User /
/Fee /
/Act /
/of /
/1922b) /
/GMPs /
/for /
/the /
/21st /
/Century /
/initiative /
/c) /
/Food /
/and /
/Drug /
/Administration /
/Modernization /
/Act //d) //Food //and //Drug //Administration //Amendments //Act(1:4) //- //verified //answer(s)-
✔✔C: //Food //and //Drug //Administration //Modernization //Act
,//////////////////////////////////////////////////////////////////
Both //regulations //and //guidance //documents //have //the //force //of //law. //True //or //False?
(2:1) //- //verified //answer(s)-✔✔False. //Only //regulations //have //the //force //of //law.
Although /
/FDA's /
/statutory /
/authority /
/does /
/not /
/extend /
/to /
/the /
/occupational /
/safety /
/and /
/health /
/responsibilities /
/of /
/OSHA /
/the /
/agencies /
/coordinate /
/their //efforts //in //matters //of //related //responsibility //such //as //unshielded //syringes //and //natural
//rubber //latex. //True //or //False?(2:2) //- //verified //answer(s)-✔✔True
An /
/FDA /
/petition /
/much /
/contain /
/which /
/of //the //following? //a) //Action //requested //b) //Statement //of //grounds //c) //Environmental //impact
//d) //All //of //the //above(2:3) //- //verified //answer(s)-✔✔D: //All //of //the //above
, //////////////////////////////////////////////////////////////////
Drugs //may //be //eligible //for //over-the-
counter /
/status /
/when: /
/a) /
/They /
/have /
/been /
/marketed /
/to //
a/
/material /
/extent /
/b) /
/They /
/have /
/been /
/marketed /
/for //
a/
/material /
/time //c) //Are //generally //recognized //as //safe //d) //All //of //the //above(2:4) //- //verified //answer(s)-
✔✔D: //All //of //the //above
Biologics //are //cleared //for //marketing //through //which //process //?
a) /
/Establishment /
/License /
/Application /
/(ELA)b) /
/Product /
/License /
/Application /
/(PLA)c) //Biologics //License //Application //(BLA)d) //All //of //the //above(2:5) //- //verified //answer(s)-
✔✔C: //Biologics //License //Application //(BLA)
RAC /
Exam practice questions with correct answers
/ // // // // //
Which /
/of /
/the /
/following /
/was /
/NOT //
a/
/requirement /
/of /
/the /
/original //Food //Drug //and //Cosmetic //Act //of //1938? //a) //Proof //of //efficacy //b) //Proof //of //safety //c)
//Authorized /
/standards /
/of /
/identify /
/d) //Safe //tolerances //for //unavoidable //poisonous //substances(1:1) //- //verified //answer(s)-
✔✔A: //Proof //of //efficacy
Which /
/amendments //to //the //FD&C //Act //resulted //from //the //thalidomide //tragedy? //a) //Durham-
Humphrey //Amendments //b) //Hatch-Waxman //Act //c) //Controlled //Substances //Act //d) //Kefauver-
Harris //Amendments //(1:2) //- //verified //answer(s)-✔✔D: //Kefauver-Harris //Amendments
The /
/Color /
/Additive /
/Amendment /
/of /
/1960 /
/required /
,//////////////////////////////////////////////////////////////////
/FDA /
/to /
/prove /
/that //
a/
/color /
/additive /
/was /
/unsafe //before //removing //it //from //the //market. //a) //True //b) //False(1:3) //- //verified //answer(s)-
✔✔B: //False
What //has //been //described //as //"the //most //extensive //change //to //the //agency's //practices //since
//1938?" /
/a) /
/Prescription /
/Drug /
/User /
/Fee /
/Act /
/of /
/1922b) /
/GMPs /
/for /
/the /
/21st /
/Century /
/initiative /
/c) /
/Food /
/and /
/Drug /
/Administration /
/Modernization /
/Act //d) //Food //and //Drug //Administration //Amendments //Act(1:4) //- //verified //answer(s)-
✔✔C: //Food //and //Drug //Administration //Modernization //Act
,//////////////////////////////////////////////////////////////////
Both //regulations //and //guidance //documents //have //the //force //of //law. //True //or //False?
(2:1) //- //verified //answer(s)-✔✔False. //Only //regulations //have //the //force //of //law.
Although /
/FDA's /
/statutory /
/authority /
/does /
/not /
/extend /
/to /
/the /
/occupational /
/safety /
/and /
/health /
/responsibilities /
/of /
/OSHA /
/the /
/agencies /
/coordinate /
/their //efforts //in //matters //of //related //responsibility //such //as //unshielded //syringes //and //natural
//rubber //latex. //True //or //False?(2:2) //- //verified //answer(s)-✔✔True
An /
/FDA /
/petition /
/much /
/contain /
/which /
/of //the //following? //a) //Action //requested //b) //Statement //of //grounds //c) //Environmental //impact
//d) //All //of //the //above(2:3) //- //verified //answer(s)-✔✔D: //All //of //the //above
, //////////////////////////////////////////////////////////////////
Drugs //may //be //eligible //for //over-the-
counter /
/status /
/when: /
/a) /
/They /
/have /
/been /
/marketed /
/to //
a/
/material /
/extent /
/b) /
/They /
/have /
/been /
/marketed /
/for //
a/
/material /
/time //c) //Are //generally //recognized //as //safe //d) //All //of //the //above(2:4) //- //verified //answer(s)-
✔✔D: //All //of //the //above
Biologics //are //cleared //for //marketing //through //which //process //?
a) /
/Establishment /
/License /
/Application /
/(ELA)b) /
/Product /
/License /
/Application /
/(PLA)c) //Biologics //License //Application //(BLA)d) //All //of //the //above(2:5) //- //verified //answer(s)-
✔✔C: //Biologics //License //Application //(BLA)
