RAC Exam practice Questions and Answers with Certified Solutions

RAC Exam practice Questions and Answers with Certified Solutions 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) 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) 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) 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) C: Food and Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) 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) 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) 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) 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) C: Biologics License Application (BLA) A Special 510(k) relies on the following information: a) Design control documentation b) Guidance documents c) Consensus standards d) All of the above(2:6) A: Design control documentation Which act required rulemaking meetings to be open to the public? a) Moonshine Act b) Government in the Sunshine Act c) Food Drug and Cosmetics Act d) Administrative Amendments Act(2:7) B: Government in the Sunshine Act Which of the following does not distinguish the development of drugs for animal use from those for human use: a) The ability to use known data from the development of a drug for use in humans or other animal species as applicable. b) Generally safety and efficacy studies require only 10s of animals per group compared to the 100s of patients per group required for human drugs. c) Does not have user fees for NADAs. d) Species class and breed of animals as well as geographical differences are more relevant.(3:1) C: Does not have user fees for NADAs. A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90% confidence intervals for the ratio of population geometric means between the two treatments based on log-transformed data is contained within the