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