RAC US Exam Solved Combined
Questions With Revised Correct Detailed
Answers
1938 FD&C Act - Answer -pivotal safety and labeling requirements; defined "drug"
1901 Virus-Toxin Law (Biologics Control Act) - Answer -biologic establishment licensing,
manufacturer inspections & premarket approval
1906 Food & Drugs Act - Answer -prohibited marketing of adulterated and misbranded
food and drugs
351(a) - Answer -application for approval of new biological entity
505(b)(1) - Answer -new drug application
505(b)(2) - Answer -nda relying in part on data not developed by applicant
505(j) - Answer -generic drug application; requires bioequivalence and bioavailability
CDER or CBER? cytokines - Answer -CDER
CDER or CBER? growth factors - Answer -CDER
CDER or CBER? enzymes - Answer -CDER
CDER or CBER? immunomodulators - Answer -CDER
CDER or CBER? allergenic extracts - Answer -CBER
CDER or CBER? blood & related - Answer -CBER
CDER or CBER? tissue & cells - Answer -CBER
CDER or CBER? gene therapy - Answer -CBER
CDER or CBER? vaccines - Answer -CBER
CDER or CBER? devices & test kits - Answer -CBER
IND required for.... - Answer -clinical study of new drug or biologic; interstate shipment
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