RAC DRUGS EXAM SCRIPT PREMIUM
REVIEW SHEET TESTED 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?
REVIEW SHEET TESTED 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?
