US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed
9 views 0 purchase
Course
US RAC
Institution
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller SterlingScores. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.84. You're not tied to anything after your purchase.
