RAPS RAC (DRUG) PRACTICE TEST
EXAM UPDATED QUESTIONS AND
CORRECT ANSWERS.
Which of the following is NOT a reason to file an OMOR? - ANS Switch a product from
prescription to over-the-counter.
You are a manufacturer in the US, and you discover that your company's top selling product in
the last two years has been used off-label. The off-label use is estimated to be about 70%, and
it has been consistent since the product was first released to the market. Which of the
following is the MOST appropriate next step? - ANS Discuss with regulatory authorities to
investigate how to have the off-label indication approved.
A pharmaceutical company is developing a new drug. Which of the following scenarios would
most likely require extensive safety pharmacology studies? - ANS It is a biotechnology-
derived product that represents a novel therapeutic class.
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine a blood donor's
hematocrit prior to donation. The firm should address the 510(k) submission to: - ANS CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted
dossier? - ANS Quality Overall Summary
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, Blood Center ABC has just opened in a Midwestern state. It plans to manufacture blood and
blood products from volunteer blood donors and offer these products for sale to local dialysis
clinics and hospitals in other states. Blood Center ABC must: - ANS Register with FDA within
five days after beginning operations and provide a current list of all products manufactured,
prepared and processed that are in commercial distribution.
FDA CDER encourages submission of a human factor's validation protocol for review prior to the
execution of the study. What is the most appropriate mechanism by which a sponsor should
use to get FDA's feedback on the protocol? - ANS Submit the protocol to the IND.
Investigational combination products that include a device constituent part are subject to
which provision of 21 CFR part 820? - ANS Design Controls (21 CFR 820.30) unless the device
constituent part is exempt from design controls.
Which U.S. agency makes the first assessment of a new drug's potential for addiction and/or
abuse? - ANS FDA
Which of the following statements about biosimilars is NOT correct? - ANS Biosimilars are
considered as generic pharmaceuticals and use the same marketing review procedures.
Your engineering department would like to install a different mixer for use in solid dosage
forms, and validate it for interchangeable use with an existing mixer. Changing between which
of the following pairs of blenders would be considered the least likely to impact product
quality? - ANS Double cone blender and bin blender
Which of the following is the purpose of an end-of-Phase 2 meeting between the IND sponsor
and the FDA? - ANS To evaluate the pivotal study design.
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim in the labeling, while the FDA is
proposing a more restrictive claim. What is the regulatory professional's BEST course of action?
- ANS Negotiate with the review division.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
EXAM UPDATED QUESTIONS AND
CORRECT ANSWERS.
Which of the following is NOT a reason to file an OMOR? - ANS Switch a product from
prescription to over-the-counter.
You are a manufacturer in the US, and you discover that your company's top selling product in
the last two years has been used off-label. The off-label use is estimated to be about 70%, and
it has been consistent since the product was first released to the market. Which of the
following is the MOST appropriate next step? - ANS Discuss with regulatory authorities to
investigate how to have the off-label indication approved.
A pharmaceutical company is developing a new drug. Which of the following scenarios would
most likely require extensive safety pharmacology studies? - ANS It is a biotechnology-
derived product that represents a novel therapeutic class.
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine a blood donor's
hematocrit prior to donation. The firm should address the 510(k) submission to: - ANS CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted
dossier? - ANS Quality Overall Summary
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, Blood Center ABC has just opened in a Midwestern state. It plans to manufacture blood and
blood products from volunteer blood donors and offer these products for sale to local dialysis
clinics and hospitals in other states. Blood Center ABC must: - ANS Register with FDA within
five days after beginning operations and provide a current list of all products manufactured,
prepared and processed that are in commercial distribution.
FDA CDER encourages submission of a human factor's validation protocol for review prior to the
execution of the study. What is the most appropriate mechanism by which a sponsor should
use to get FDA's feedback on the protocol? - ANS Submit the protocol to the IND.
Investigational combination products that include a device constituent part are subject to
which provision of 21 CFR part 820? - ANS Design Controls (21 CFR 820.30) unless the device
constituent part is exempt from design controls.
Which U.S. agency makes the first assessment of a new drug's potential for addiction and/or
abuse? - ANS FDA
Which of the following statements about biosimilars is NOT correct? - ANS Biosimilars are
considered as generic pharmaceuticals and use the same marketing review procedures.
Your engineering department would like to install a different mixer for use in solid dosage
forms, and validate it for interchangeable use with an existing mixer. Changing between which
of the following pairs of blenders would be considered the least likely to impact product
quality? - ANS Double cone blender and bin blender
Which of the following is the purpose of an end-of-Phase 2 meeting between the IND sponsor
and the FDA? - ANS To evaluate the pivotal study design.
A regulatory professional is negotiating with the FDA on a product's final labeling. The
company's management is adamant about including a claim in the labeling, while the FDA is
proposing a more restrictive claim. What is the regulatory professional's BEST course of action?
- ANS Negotiate with the review division.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
