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RAPS RAC (Drug) Practice Test
Questions and Answers Latest 2026
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
© 2025 All rights reserved
, 2 | Page
In the EU, which type of documentation should NOT be
included in Module 1 of a submitted dossier? Ans:
Quality Overall Summary
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.
© 2025 All rights reserved
, 3 | Page
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.
Within how many days after receipt MUST the FDA file, or
refuse to file, an NDA? Ans: 60
What statements would NOT be correct about an
Authorized Generic Drug? Ans: It is the same as the
brand name drug in active ingredient, conditions of use,
dosage form, strength, route of administration, and (with
certain permissible differences) labeling.
A regulatory professional receives a lengthy letter for a
BLA indicating non-approval. Which of the following
actions will restart the review clock? Ans: Submitting the
complete response.
© 2025 All rights reserved
RAPS RAC (Drug) Practice Test
Questions and Answers Latest 2026
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
© 2025 All rights reserved
, 2 | Page
In the EU, which type of documentation should NOT be
included in Module 1 of a submitted dossier? Ans:
Quality Overall Summary
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.
© 2025 All rights reserved
, 3 | Page
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.
Within how many days after receipt MUST the FDA file, or
refuse to file, an NDA? Ans: 60
What statements would NOT be correct about an
Authorized Generic Drug? Ans: It is the same as the
brand name drug in active ingredient, conditions of use,
dosage form, strength, route of administration, and (with
certain permissible differences) labeling.
A regulatory professional receives a lengthy letter for a
BLA indicating non-approval. Which of the following
actions will restart the review clock? Ans: Submitting the
complete response.
© 2025 All rights reserved
