RAPS RAC (DRUG) PRACTICE TEST QUESTIONS WITH
CORRECT ANSWERS | VERIFIED
/. Which of the following is NOT a reason to file an OMOR? - Answer-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? - 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.
/.A regulatory professional receives a lengthy letter for a BLA indicating non-approval.
Which of the following actions will restart the review clock? - Answer-Submitting the
complete response.
/.According to ICH Q10, implementing a Pharmaceutical Quality System (PQS)
addresses all of the following EXCEPT: - Answer-A PQS can be certified through the
ICH Q10 Certification Programme, reducing the frequency of inspections
/.How many days after the start of the DCP Assessment Step I does the reference
member state have to supply the draft labeling to the concerned member states and
applicant? - Answer-120
/.The current consistent adverse drug reaction terms used for product labeling originate
from which of the following? - Answer-Medical Dictionary for Regulatory Activities
/.A manufacturer wants to gain approval of an over-the-counter (OTC) product already
approved in a Reference Member State by a competitor for a different indication. Which
of the following filings are required? - Answer-File a new Marketing Authorisation
Application.
CORRECT ANSWERS | VERIFIED
/. Which of the following is NOT a reason to file an OMOR? - Answer-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? - 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.
/.A regulatory professional receives a lengthy letter for a BLA indicating non-approval.
Which of the following actions will restart the review clock? - Answer-Submitting the
complete response.
/.According to ICH Q10, implementing a Pharmaceutical Quality System (PQS)
addresses all of the following EXCEPT: - Answer-A PQS can be certified through the
ICH Q10 Certification Programme, reducing the frequency of inspections
/.How many days after the start of the DCP Assessment Step I does the reference
member state have to supply the draft labeling to the concerned member states and
applicant? - Answer-120
/.The current consistent adverse drug reaction terms used for product labeling originate
from which of the following? - Answer-Medical Dictionary for Regulatory Activities
/.A manufacturer wants to gain approval of an over-the-counter (OTC) product already
approved in a Reference Member State by a competitor for a different indication. Which
of the following filings are required? - Answer-File a new Marketing Authorisation
Application.
