RAPS RAC (DRUG) PRACTICE TEST QUESTIONS AND ANSWERS LATEST UPDATE 2025-2026
Which of the following is NOT a reason to file an OMOR? - Answers 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? - Answers 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? - Answers 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: - Answers
CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted
dossier? - Answers 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: - Answers 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? - Answers 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? - Answers 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? - Answers FDA
Which of the following statements about biosimilars is NOT correct? - Answers 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? -
Answers 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? - Answers 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?
- Answers Negotiate with the review division.
Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? - Answers 60
What statements would NOT be correct about an Authorized Generic Drug? - Answers 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? - Answers Submitting the complete response.
According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of
the following EXCEPT: - Answers 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? - Answers 120
The current consistent adverse drug reaction terms used for product labeling originate from
which of the following? - Answers 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? - Answers File a new Marketing Authorisation Application.
Which of the following statements regarding European scientific guidelines is CORRECT? -
Answers The standards do not have legal force.
A clinical trial for a medicinal product was conducted in several European countries and has
been finalized. What is the MOST appropriate next regulatory step? - Answers File a declaration
on the end of the clinical trial to the CA and ethics committees of the participating countries.
Your company is planning to place a generic, non-biologic product on the market. The original
product manufacturer's data exclusivity period is over. As a regulatory professional, how will
you advise your company to obtain a faster Marketing Authorisation? - Answers To conduct
bioavailability and bioequivalence studies to prove equivalence to the original product and refer
to the original product manufacturer's file for the rest of the documentation.
Which of the following is NOT a reason to file an OMOR? - Answers 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? - Answers 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? - Answers 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: - Answers
CBER
In the EU, which type of documentation should NOT be included in Module 1 of a submitted
dossier? - Answers 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: - Answers 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? - Answers 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? - Answers 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? - Answers FDA
Which of the following statements about biosimilars is NOT correct? - Answers 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? -
Answers 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? - Answers 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?
- Answers Negotiate with the review division.
Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? - Answers 60
What statements would NOT be correct about an Authorized Generic Drug? - Answers 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? - Answers Submitting the complete response.
According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of
the following EXCEPT: - Answers 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? - Answers 120
The current consistent adverse drug reaction terms used for product labeling originate from
which of the following? - Answers 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? - Answers File a new Marketing Authorisation Application.
Which of the following statements regarding European scientific guidelines is CORRECT? -
Answers The standards do not have legal force.
A clinical trial for a medicinal product was conducted in several European countries and has
been finalized. What is the MOST appropriate next regulatory step? - Answers File a declaration
on the end of the clinical trial to the CA and ethics committees of the participating countries.
Your company is planning to place a generic, non-biologic product on the market. The original
product manufacturer's data exclusivity period is over. As a regulatory professional, how will
you advise your company to obtain a faster Marketing Authorisation? - Answers To conduct
bioavailability and bioequivalence studies to prove equivalence to the original product and refer
to the original product manufacturer's file for the rest of the documentation.
