RAC Exam Practice Latest Questions and Answers/Complete Solutions

RAC Exam Practice Latest Questions and Answers/Complete 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) [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) [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 market. a) True b) False(1:3) [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) [Ans: - C: Food and Drug Administration Modernization Act

Both regulations and guidance documents have the force of law. True or False?(2:1) [Ans: - 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) [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) [Ans: - D: All of the above