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2014 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed Which regulatory pathway allows for faster approval of drugs that address unmet medical needs in serious conditions? A) Priority Review B) Orphan Drug Designation C) Accelerated Approval D) Fast Tra...

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  • September 25, 2024
  • 141
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • 2014 us rac practice exam questions and answers

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  • 2014 US RAC Practice
  • 2014 US RAC Practice

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2014 US RAC Practice Exam Questions
and Answers | Latest Update | 2024/2025
| Already Passed
Which regulatory pathway allows for faster approval of drugs that address unmet medical needs

in serious conditions?

A) Priority Review

B) Orphan Drug Designation


✔✔C) Accelerated Approval


D) Fast Track Designation




Which document must be provided to participants to ensure they understand the risks and

benefits of a clinical trial?

A) Investigator’s Brochure


✔✔B) Informed Consent Form


C) Clinical Study Report

D) Clinical Trial Agreement




When submitting a New Drug Application (NDA), what section contains detailed information on

the drug's formulation and manufacturing process?

1

,A) Nonclinical Studies Section


✔✔B) Chemistry, Manufacturing, and Controls (CMC) Section


C) Labeling Section

D) Clinical Studies Section




For a combination product (e.g., drug-device combination), which FDA office is responsible for

determining the primary mode of action?

A) Office of Orphan Products Development

B) Office of New Drugs


✔✔C) Office of Combination Products


D) Office of Compliance




Which FDA pathway is used for the approval of generic drugs?


✔✔A) Abbreviated New Drug Application (ANDA)


B) New Drug Application (NDA)

C) Investigational New Drug Application (IND)

D) Biologics License Application (BLA)




2

,What type of meeting is typically held between the FDA and a sponsor before submitting an

NDA or BLA to clarify the submission requirements?

A) Advisory Committee Meeting

B) Safety Update Meeting


✔✔C) Pre-NDA/BLA Meeting


D) Post-Approval Meeting




In what situation would a Humanitarian Device Exemption (HDE) be used for a medical device?


✔✔A) When the device is intended to treat fewer than 8,000 patients per year in the U.S.


B) When the device has been marketed in Europe but not in the U.S.

C) When the device is a Class III device and requires further study

D) When the device is already approved for pediatric use but not adult use




Which phase of clinical trials is primarily focused on monitoring drug safety in patients with the

disease or condition being treated?

A) Phase I


✔✔B) Phase II


C) Phase III



3

, D) Phase IV




What is required for a device manufacturer to market a new Class III medical device?

A) 510(k) submission


✔✔B) Premarket Approval (PMA)


C) Humanitarian Device Exemption (HDE)

D) Special 510(k)




Which FDA post-market program is designed to identify new safety information for drugs and

biologics after approval?

A) Orphan Drug Designation


✔✔B) FDA Sentinel Initiative


C) Investigational Device Exemption (IDE)

D) Expanded Access Program




What is required in a Breakthrough Therapy Designation application for drugs?

A) Proof of financial investment in R&D

B) Submission of marketing plans



4

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