RAC Exam practice 2023/2024 with 100% 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) - correct answer 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) - correct answer 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) - correct answer 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) - correct answer C: Food and Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) - correct answer 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) - correct answer 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) - correct answer 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) - correct answer 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) - correct answer 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) - correct answer A: Design control documentation