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US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed $10.62   Add to cart

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US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed

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US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in re...

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  • September 25, 2024
  • 37
  • 2024/2025
  • Exam (elaborations)
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  • US RAC
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US RAC Exam Prep Questions and
Answers | Latest Update | 2024/2025 |
Already Passed

Describe the purpose of a New Drug Application (NDA).


✔✔The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical

in the U.S.




What is the purpose of a combination product in regulatory terms?


✔✔It involves two or more regulated components, such as a drug and device, that work together.




Explain what an Orphan Drug Designation provides to a company.


✔✔It grants incentives like tax credits and market exclusivity for developing treatments for rare

diseases.




What is the role of a Notified Body in the European regulatory process for medical devices?


✔✔A Notified Body assesses the conformity of medical devices to ensure they meet EU

requirements.




1

,What does “Class I recall” mean in FDA terms?


✔✔It refers to a situation where a product may cause serious health consequences or death.




Describe the purpose of an Investigational Device Exemption (IDE).


✔✔An IDE allows an unapproved medical device to be used in a clinical study to collect data.




What is the key focus of the pre-submission process in medical device regulation?


✔✔It allows manufacturers to communicate with the FDA and get feedback before submitting a

regulatory application.




Define the term “pharmacovigilance” in post-market monitoring.


✔✔Pharmacovigilance involves tracking and assessing adverse drug reactions and safety after a

product is on the market.




What is the primary goal of the Common Technical Document (CTD)?


✔✔The CTD standardizes the format for submitting regulatory documents to health authorities

in different regions.




2

,Explain what is meant by “Good Clinical Practice” (GCP).


✔✔GCP is an international ethical and scientific standard for the design, conduct, and reporting

of clinical trials.




What is the role of a 510(k) submission for a medical device?


✔✔It demonstrates that the new device is substantially equivalent to a legally marketed device.




What is the importance of the Pediatric Research Equity Act (PREA)?


✔✔It requires pharmaceutical companies to assess the safety and effectiveness of new drugs in

pediatric populations.




Define the term “clinical endpoint” in the context of a clinical trial.


✔✔A clinical endpoint is a measurable outcome used to judge the effectiveness of a treatment.




What does a Biologics License Application (BLA) cover?


✔✔A BLA is submitted to the FDA for the approval of biologic products like vaccines or gene

therapies.




3

, What is the purpose of a Risk Management Plan (RMP) in drug safety?


✔✔An RMP outlines strategies to identify, evaluate, and mitigate risks associated with a drug

throughout its lifecycle.




What is a Certificate of Free Sale in international regulatory submissions?


✔✔It confirms that a product is legally marketed in its country of origin and can be exported.




What is the significance of “Fast Track Designation” by the FDA?


✔✔It is designed to expedite the review of drugs that treat serious conditions and fill an unmet

medical need.




What is required for a medical device to receive a CE mark in Europe?


✔✔It must meet the regulatory requirements of the EU Medical Device Regulation (MDR) and

pass assessment by a Notified Body.




30-day hold ✔✔(aka 30-day safety review) Time frame between filing a protocol under an IND

and the FDA approval to proceed with enrollment. Also, the time period between when a

company submits an IND and when it can initiate a protocol. This timeline may be extended if

FDA does not agree with the proposed protocol. (see "Clinical Hold.")


4

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