RAC Exam practice test bank 2024 all possible questions and answers with complete solution 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 unavoidab le poisonous substances(1:1) - 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) - 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) - Answer ✔️✔️-B: False What has been described as "the most extensi ve 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) - Answer ✔️✔️-C: Food an d Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) - Answer ✔️✔️-False. Only regulations have the force of law. Although FDA's statutory authority does not extend to the occupational s afety 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) - Answer ✔️✔️-True An FDA petition much contain which of the foll owing? a) Action requested b) Statement of grounds c) Environmental impact d) All of the above(2:3) - 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) - 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) - 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) A ll of the above(2:6) - Answer ✔️✔️-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) - Answer ✔️✔️-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 spec ies 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) - Answer ✔️✔️-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 me ans 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) - Answer ✔️✔️-D: 80% and 125% What is the definition of a biologic?(3:3) - Answer ✔️✔️-A substance derived from or made with the aid of living organisms. What are the major categories of ICH guidelines?(3:4) - Answer ✔️✔️-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) - Answer ✔️✔️-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) - Answer ✔️✔️-C: Federal Regi ster What five types of application meetings are available to sponsors submitting medical devices to CDRH?(4:2) - Answer ✔️✔️-Agreement Determination Pre -IDE Pre -PMA and PMA day -100 Under what circumstances is it appropriate to request a Type A meeting?(4: 3) - Answer ✔️✔️-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 to review the safety and efficacy of an NDC is a public hearing before the commissioner. (4:4) - Answer ✔️✔️-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 committee 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) - Answer ✔️✔️-False: Advisory committee meetings may be closed but no advisory co mmittee meeting can be completely closed (21 CFR 14.27) True or False: FDA advisory committees provide independent expert advice and credibility to product reviews. (5:2) - Answer ✔️✔️-True Where can you find guidance on the time frames for preparing brief ing materials for an advisory committee meeting?(5:3) - Answer ✔️✔️-"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 advis ory committees within FDA.(5:4) - Answer ✔️✔️-True
Humphrey Amendments b) Hatch -Waxman Act c) Controlled Substances Act d) Kefauver -
Harris Amendments (1:2) - 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) - Answer ✔️✔️-B: False What has been described as "the most extensi ve 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) - Answer ✔️✔️-C: Food an d Drug Administration Modernization Act Both regulations and guidance documents have the force of law. True or False?(2:1) - Answer ✔️✔️-False. Only regulations have the force of law. Although FDA's statutory authority does not extend to the occupational s afety 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) - Answer ✔️✔️-True An FDA petition much contain which of the foll owing? a) Action requested b) Statement of grounds c) Environmental impact d) All of the above(2:3) - 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) - 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) - 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) A ll of the above(2:6) - Answer ✔️✔️-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) - Answer ✔️✔️-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 spec ies 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) - Answer ✔️✔️-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 me ans 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) - Answer ✔️✔️-D: 80% and 125% What is the definition of a biologic?(3:3) - Answer ✔️✔️-A substance derived from or made with the aid of living organisms. What are the major categories of ICH guidelines?(3:4) - Answer ✔️✔️-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) - Answer ✔️✔️-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) - Answer ✔️✔️-C: Federal Regi ster What five types of application meetings are available to sponsors submitting medical devices to CDRH?(4:2) - Answer ✔️✔️-Agreement Determination Pre -IDE Pre -PMA and PMA day -100 Under what circumstances is it appropriate to request a Type A meeting?(4: 3) - Answer ✔️✔️-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 to review the safety and efficacy of an NDC is a public hearing before the commissioner. (4:4) - Answer ✔️✔️-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 committee 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) - Answer ✔️✔️-False: Advisory committee meetings may be closed but no advisory co mmittee meeting can be completely closed (21 CFR 14.27) True or False: FDA advisory committees provide independent expert advice and credibility to product reviews. (5:2) - Answer ✔️✔️-True Where can you find guidance on the time frames for preparing brief ing materials for an advisory committee meeting?(5:3) - Answer ✔️✔️-"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 advis ory committees within FDA.(5:4) - Answer ✔️✔️-True
