RAC STUDY GUIDE 2026 COMPREHENSIVE
QUESTIONS AND 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.
QUESTIONS AND 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.
