PRACTICE RAC ACTUAL EXAM SCRIPT
2026 QUESTIONS WITH CORRECT
ANSWERS
⩥ 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? Answer: 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? Answer: 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: Answer:
CBER
⩥ In the EU, which type of documentation should NOT be included in
Module 1 of a submitted dossier? Answer: 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: Answer: 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? Answer: 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? Answer: 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? Answer: FDA
⩥ Which of the following statements about biosimilars is NOT correct?
Answer: 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?
Answer: 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? Answer: 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?
Answer: Negotiate with the review division.
⩥ Within how many days after receipt MUST the FDA file, or refuse to
file, an NDA? Answer: 60
⩥ What statements would NOT be correct about an Authorized Generic
Drug? Answer: 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.
2026 QUESTIONS WITH CORRECT
ANSWERS
⩥ 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? Answer: 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? Answer: 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: Answer:
CBER
⩥ In the EU, which type of documentation should NOT be included in
Module 1 of a submitted dossier? Answer: 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: Answer: 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? Answer: 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? Answer: 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? Answer: FDA
⩥ Which of the following statements about biosimilars is NOT correct?
Answer: 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?
Answer: 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? Answer: 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?
Answer: Negotiate with the review division.
⩥ Within how many days after receipt MUST the FDA file, or refuse to
file, an NDA? Answer: 60
⩥ What statements would NOT be correct about an Authorized Generic
Drug? Answer: 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.
