RAC Exam practice Questions & Answers 2023 Review Update Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficac y b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - Correct Ans ->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 Ans ->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 mark et. a) True b) False(1:3) - Correct Ans ->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 Ans -
>C: Food and Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) - Correct Ans -
>False. Only regulatio ns 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 Ans ->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 Ans ->D: All of the above Drugs may be eligib le 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 Ans ->D: All of the above Biologics are cleared for m arketing 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 Ans->C: Biologics License Application (BLA) A Special 510(k) relies on t he following information: a) Design control documentation b) Guidance documents c) Consensus standards d) All of the above(2:6) - Correct Ans ->A: Design control documentation Which act required rulemaking meetings to be open to the public? a) Moonshine Ac t b) Government in the Sunshine Act c) Food Drug and Cosmetics Act d) Administrative Amendments Act(2:7) - Correct Ans -
>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 e fficacy 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) - Correct Ans ->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 equivalence limits of ____% - ____% for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - Correct Ans ->D: 80% and 125% What is the definition of a biologic?(3:3) - Correct Ans ->A substance derived from or made with the aid of living organisms. What are the major categories of ICH guidelines?(3:4) - Correct Ans ->Quality Safety Efficacy Multidisciplinary What is the deadline for an initial IND Safety report of a fatal or life -threatening serious adverse event?(3:5) - Correct Ans ->7 days FDA promulgates regulations in which of the following? a) Code of Federal Regulations b) Docket Management System c) Federal Register d) Federal Docket(4:1) - Correct Ans ->C: Federal Register What five types of applicat ion meetings are available to sponsors submitting medical devices to CDRH?(4:2) - Correct Ans ->Agreement Determination Pre -IDE Pre -PMA and PMA day -100 Under what circumstances is it appropriate to request a Type A meeting?(4:3) - Correct Ans ->The Type A meeting is one that is immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings are reserved for dispute resolution discussion of clinical holds and special protocol assessment meetings. True or False: A hearing t o review the safety and efficacy of an NDC is a public hearing before the commissioner. (4:4) - Correct Ans ->False. A hearing to review the safety and efficacy of an NDA is a public hearing before a public advisory committee. True or False: FDA advisory c ommittee meetings may be completely closed to the public and notice of a meeting is not required to be published until the day of the meeting. (5:1) - Correct Ans ->False: Advisory committee meetings may be closed but no advisory committee meeting can be co mpletely closed (21 CFR 14.27) True or False: FDA advisory committees provide independent expert advice and credibility to product reviews. (5:2) - Correct Ans ->True Where can you find guidance on the time frames for preparing briefing materials for an a dvisory committee meeting?(5:3) - Correct Ans ->"Guidance for Industry Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members (August 2008)" True or False: There are 31 advisory committees withi n FDA.(5:4) - Correct Ans ->True
>C: Food and Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) - Correct Ans -
>False. Only regulatio ns 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 Ans ->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 Ans ->D: All of the above Drugs may be eligib le 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 Ans ->D: All of the above Biologics are cleared for m arketing 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 Ans->C: Biologics License Application (BLA) A Special 510(k) relies on t he following information: a) Design control documentation b) Guidance documents c) Consensus standards d) All of the above(2:6) - Correct Ans ->A: Design control documentation Which act required rulemaking meetings to be open to the public? a) Moonshine Ac t b) Government in the Sunshine Act c) Food Drug and Cosmetics Act d) Administrative Amendments Act(2:7) - Correct Ans -
>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 e fficacy 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) - Correct Ans ->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 equivalence limits of ____% - ____% for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - Correct Ans ->D: 80% and 125% What is the definition of a biologic?(3:3) - Correct Ans ->A substance derived from or made with the aid of living organisms. What are the major categories of ICH guidelines?(3:4) - Correct Ans ->Quality Safety Efficacy Multidisciplinary What is the deadline for an initial IND Safety report of a fatal or life -threatening serious adverse event?(3:5) - Correct Ans ->7 days FDA promulgates regulations in which of the following? a) Code of Federal Regulations b) Docket Management System c) Federal Register d) Federal Docket(4:1) - Correct Ans ->C: Federal Register What five types of applicat ion meetings are available to sponsors submitting medical devices to CDRH?(4:2) - Correct Ans ->Agreement Determination Pre -IDE Pre -PMA and PMA day -100 Under what circumstances is it appropriate to request a Type A meeting?(4:3) - Correct Ans ->The Type A meeting is one that is immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings are reserved for dispute resolution discussion of clinical holds and special protocol assessment meetings. True or False: A hearing t o review the safety and efficacy of an NDC is a public hearing before the commissioner. (4:4) - Correct Ans ->False. A hearing to review the safety and efficacy of an NDA is a public hearing before a public advisory committee. True or False: FDA advisory c ommittee meetings may be completely closed to the public and notice of a meeting is not required to be published until the day of the meeting. (5:1) - Correct Ans ->False: Advisory committee meetings may be closed but no advisory committee meeting can be co mpletely closed (21 CFR 14.27) True or False: FDA advisory committees provide independent expert advice and credibility to product reviews. (5:2) - Correct Ans ->True Where can you find guidance on the time frames for preparing briefing materials for an a dvisory committee meeting?(5:3) - Correct Ans ->"Guidance for Industry Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members (August 2008)" True or False: There are 31 advisory committees withi n FDA.(5:4) - Correct Ans ->True
