RAPS RAC (Drug) Practice Test
Which of the following is NOT a reason to file an OMOR? -
☑️ 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? -
☑️ 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? -
☑️ 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: -
☑️ CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier?
-
☑️ 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: -
☑️ 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? -
☑️ 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? -
☑️ 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? -
☑️ FDA
Which of the following statements about biosimilars is NOT correct? -
, ☑️ 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? -
☑️ 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? -
☑️ 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? -
☑️ Negotiate with the review division.
Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? -
☑️ 60
What statements would NOT be correct about an Authorized Generic Drug? -
☑️ 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? -
☑️ Submitting the complete response.
According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of the
following EXCEPT: -
☑️ 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? -
☑️ 120
The current consistent adverse drug reaction terms used for product labeling originate from which of
the following? -
☑️ 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? -
☑️ File a new Marketing Authorisation Application.
Which of the following statements regarding European scientific guidelines is CORRECT? -
Which of the following is NOT a reason to file an OMOR? -
☑️ 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? -
☑️ 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? -
☑️ 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: -
☑️ CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier?
-
☑️ 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: -
☑️ 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? -
☑️ 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? -
☑️ 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? -
☑️ FDA
Which of the following statements about biosimilars is NOT correct? -
, ☑️ 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? -
☑️ 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? -
☑️ 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? -
☑️ Negotiate with the review division.
Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? -
☑️ 60
What statements would NOT be correct about an Authorized Generic Drug? -
☑️ 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? -
☑️ Submitting the complete response.
According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of the
following EXCEPT: -
☑️ 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? -
☑️ 120
The current consistent adverse drug reaction terms used for product labeling originate from which of
the following? -
☑️ 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? -
☑️ File a new Marketing Authorisation Application.
Which of the following statements regarding European scientific guidelines is CORRECT? -
