2022/2023 Practice RAC Exam Questions and Answers (100% Pass)

A new chemical isintroduced into a manufacturing facility. The regulatory affizirs practitioner must ensure thatwhich ofthe fOllowing documents are availablefOr the chemical? A DOT manifest B. MSDS e. Interstate Bill of Lading D. USP monograph - Answer-B. MSDS A This document is not usually required by the manufacturer B. B. The information contained in the MSDS must be disseminated as mandated by OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state "employee right to know" laws. Failure to comply may expose the company to legal risk. C. This document is not usually required by the manufacturer. D. This may contain useful information about certain chemicaJs, but there is no statutory mandate that they be available. When assembling an NDA, all of the following FDA guidelines are used EXCEPT: A. environmental assessment of human drugs and biologics application. B. preparation of an IND product. C. format and content of an application summary. D. format and content of clinical and statistical sections. - Answer-B. preparation of an IND product. A. This is a guidance document that will help the regulatory professional assemble an NDA B. This guidance is useful in describing how to assemble an IND, the phase of drug development that precedes an NDA C.This is a guidance document that will help the regulatory professional assemble an NDA D.This is a guidance document that will help the regulatory professional assemble an NDA Under the IDE regulation, all of the following must be reported to the sponsor within 5 days EXCEPT: A. a deviation from the investigational plan. B. withdrawal of IRB approval. C. an unanticipated adverse device effect. D. use of a device without informed consent. - Answer-C. an unanticipated adverse device effect. A. The investigator should notify the sponsor within 5 days. B. Withdrawal of IRB approval is reponed within 5 days. C. The investigator notifies the sponsor and IRB within 10 days of notification of any unanticipated adverse effect. 21 CFR 812.150 D. The investigator reports to the sponsor and IRB within 5 days after this occurs. In reviewing a single-dose protocol for an oral dosage in vivo bioequivalence study on 48 subjects, the regulatory affairs practitioner would make which of the following recommendations? A. Three different batches of both the drug and reference products should be used, each on 8 patients. B. A laboratory batch of at least 5,000 tablets may be used if it meets all final product specifications. C. The study should be crossover in design and should provide for a drug elimination period. D. The study should be conducted in 3 separate locations to minimize demographic differences. - Answer-C. The study should be crossover in design and should provide for a drug elimination period. A This has too many parameters, too few patients per lot and no crossover control. B. Size of the laboratory batch is irrelevant to study design. C. Crossover uses patients as their own controls and the elimination phase prevents carryover effect from previous dose. 21 CFR 320.26 · D. This has too many unnecessary parameters and has no crossover control. Recall status reports are usually provided to FDA every two to four weeks during the time period of a recall. Submission of these reports may cease when which of the following occurs? A. FDA terminates the recall. B. Most of the affected products have been recovered. e. All of the product consignees have been notified. D. The problem which caused the recall has been corrected. - Answer-A. FDA terminates the recall. A. Only FDA can officially terminate a recall. 21 CFR 7.53 B. This is not acceptable. C. The affected product may still be unrecovered or unaccounted for. D. See explanation C.