RAC Exam practice US RAC Exam Prep Latest Update 2024-2025 300+ Questions and Verified Correct Answers Guaranteed A+ 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 ANSWER: D: 80% and 125%
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to multiple sites. Which of the following statements are true? a) Each contract facility must be listed in its own establishment license application (ELA). b) Each contract facility must be listed in the BLA. c) Each contract facility must appear in the product labeling.
d) Each contract facility must take responsibility for compliance with applicable
establishment and product requirements for biologics. e) b and d f) All of the above(22:1) - CORRECT ANSWER: e) b:Each contract facility must be listed in the BLA and d: Each contract facility must take responsibility for compliance with applicable establishment and product requirements for biologics.
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
According to the regulations under 21 CFR 3 PMOA is defined as: a) "the simplest action of a product that provides the most important therapeutic action of the combination product" b) "the basic therapeutic action of a combination product that provides the most important intended use" c) "the single mode of action of a combination product that provides the most important therapeutic action of the combination product" d) "the modes of activity of a combination product that act the most important intended use of the combination product" e) None of the above(25:4) - CORRECT ANSWER: c) "the single mode of action of a combination product that provides the most important therapeutic action of the combination product"
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 investigator / inspector should review the following when inspecting the different processes of a blood donation center: a) the accuracy availability and appropriateness of procedures b) personnel are qualified trained and adequate in number for the operations c) the facility is appropriate for the operations adequately maintained d) equipment is maintained in a manner to ensure it will perform as intended
- records are maintained such that each step can be traced and provided a complete 1 / 4
history of work performed f) all of the above.(27:5) - CORRECT ANSWER: f) all of the above.
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
An independent peer-reviewed journal article on an off-label use of an approved biologic may be disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0 days f) 30 days g) 60 days h) 3 months(24:3) -
CORRECT ANSWER: g) 60 days
Biological products are approved for marketing under provisions of: a) Food Drug and Cosmetic Act b) Acceptable GMP inspection c) Public Heath Service Act d) a and be) All of the above(22:3) - CORRECT ANSWER: e) 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)
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.
clinical trial. - CORRECT ANSWER:
Corrections to the signed and dated final study report may be made in the form of a report amendment by the: a) Quality Assurance Unit b) Test Facility Management c) Study Directory d) Any of the above e) None of the above(6:5) - CORRECT ANSWER:
C: Study Director
Devices could be misbranded for: a) not providing adequate directions for use b) not stating performance claims for the device c) not providing enough information on the risks d) a and c e) a b and c(20:4) - CORRECT ANSWER: e) a(not providing adequate directions for use) b(not stating performance claims for the device) and c(not providing enough information on the risks)
Does the clinical trial database apply to drugs or devices? (8:2) - CORRECT ANSWER: Drugs
Does the Quality System Regulation apply to drugs or devices?(8:1) - CORRECT
ANSWER: Devices
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 2 / 4
FDA and FTC share responsibilities in regulating healthcare products. FDA has authority over labeling plus: a) the advertising of OTC drugs b) the advertising or prescription drugs c) the advertising of restricted devices d) a and be) b and c(20:1) - CORRECT ANSWER: e) b(the advertising or prescription drugs) and c(the advertising of restricted devices)
FDA approved labeling is part of the submission process with: a) PMA 510(k) b) PMA BLA and NDA c) PMA and IDE d) ASR 510(k) and PMA(20:5) - CORRECT ANSWER:
b) PMA BLA and NDA
FDA interprets its regulatory authority over labeling to include: a) Bottle labels b) Package inserts c) Medication Guides d) Promotional materials e) a b and c f) a b c and d(17:1) - CORRECT ANSWER: f) a (bottle labels) b (Package inserts) c (Medication Guides) and d (Promotional materials)
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
ANSWER: C: Federal Register
FDAs inspection strategy uses a system-based approach identifying five elements in blood establishment operations required to achieve the five layers of protection for the blood supply. Which are the five elements? a) Quality Control System Donor Eligibility Product Testing Quality Assurance Release Testing and Donor Requiting System. b) Quality Assurance System Donor (Suitability) Eligibility Product Testing System Quarantine/Inventory Management System and Production and Processing System c) Quality Laboratory Practices System Donor (Suitability) eligibility Product Testing System Quarantine/Inventory Management System and Production and Processing System.(27:3) - CORRECT ANSWER: b) Quality Assurance System Donor (Suitability) Eligibility Product Testing System Quarantine/Inventory Management System and Production and Processing System
For a device to be cleared under a traditional 510(k) a product sponsor must prove to FDA that: a) the new device has the same intended use as a previously cleared device
- the new device is substantially equivalent to a previously cleared device c) the new
device improves on the technology of a previously cleared device.(21:4) - CORRECT ANSWER: b) the new device is substantially equivalent to a previously cleared device
How often does n establishment need to register with FDA? a) Once b) Annually c) Biannually d) Every five years unless the establishment's address has changed.(19:2) -
CORRECT ANSWER: b) Annually
If a biological company that FDA believes is causing an imminent hazard to public heath refuses to grant FDA access to inspect FDA would be justified (by regulation) is using which of the following enforcement options? a) Issue a Warning Letter b) Immediately suspend the license c) Issue a "Notice to Revoke" d) Issue an Injunction e) 3 / 4
Generate adverse publicity f) b and c(23:1) - CORRECT ANSWER: f) b: Immediately
suspend the license and c: Issue a "Notice to Revoke"
If a company wants to seek approval of a proposed drug product in a new capsule dosage form (the listed drug upon which the generic applicant would rely is in a table
dosage form) what type of submission should be made to FDA?(14:1) - CORRECT
ANSWER: The company could seek approval of either an ANDA pursuant to an
approved suitability petition or the company could submit a 505(b)(2) application.
If a product contains both a drug active ingredient and a dietary supplement can it be marketed as a dietary supplement? a) Yes b) No c) Only if it makes no drug claims d)
Only if contains both Drug Facts labeling and Supplement Facts labeling(16:2) -
CORRECT ANSWER: c) Only if it makes no drug claims.
If the company in question 1 (14:1) decides to submit a 505(b)(2) application containing only comparative bioequivalence/bioavailability information would that applicant qualify for a period of three-year exclusivity?(14:2) - CORRECT ANSWER: No. In order for a company to qualify for three-year exclusivity the sponsor must submit "reports of new clinical investigations (other than bioavailability studies) " that are "essential to approval" of the application and that are "conducted or sponsored by" the applicant.
If two or more biotech manufacturers are each registered with FDA and licensed to manufacture a product in its entirety they are what type of manufacturing arrangement?
a) Sole b) Short supply c) Divided d) Shared e) Contract(22:4) - CORRECT ANSWER:
c) Divided
If you had an orphan drug which meets the criteria for unmet need and in which no alternative therapies exist devise a regulatory strategy to get the drug to market in the shortest and most effective way.(12:6) - CORRECT ANSWER: The shortest and most effective way to get the product to market would be under the accelerated approval regulations. Accelerated approval is granted for drugs that treat serious or life- threatening illnesses for which no alternative treatments exist and is based on a surrogate or clinical endpoint.
Industry representatives are/are not voting members of an advisory committee because they are independent of the sponsor company and represent the industry as a whole.(5:5) - CORRECT ANSWER: Industry members are non-voting members of an advisory committee. (21 CFR 14.84)
List at least two criteria that distinguish the Privacy Rule from the Common Rule?(7:3) - CORRECT ANSWER: The Privacy Rule applies to a covered entity's use or disclosure of PHI for any research purposes regardless of funding or what agency has regulatory authority over the research. Under the Common Rule the scope of the FDA Protection of Human Subject Regulations applies only to research over which FDA has jurisdiction primarily research involving investigational products.
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