PRACTICE RAC COMPREHENSIVE EXAM
2026 QUESTIONS AND SOLUTIONS 100%
PASS
⩥ 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.
⩥ Which of the following statements regarding European scientific
guidelines is CORRECT? Answer: 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? Answer: 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? Answer: 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.
⩥ What advice should the regulatory professional give a clinical trial
sponsor on the content required for the label on a study drug? Answer:
For sites in the EU, the labeling must specify the period of use for the
product.
⩥ A clinical investigator would like to use an investigational medicinal
product to treat a gravely ill patient who does not meet the protocol
inclusion criteria. However, in the expert opinion of the clinical
investigator, the product would be the best option for that patient. What
action is MOST appropriate for the clinical investigator to take? Answer:
Obtain approval from the CA for compassionate use of the product for
this particular patient.
⩥ A variation for a complex manufacturing change should include which
of the following? Answer: An expert statement and CV from a quality
expert.
2026 QUESTIONS AND SOLUTIONS 100%
PASS
⩥ 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.
⩥ Which of the following statements regarding European scientific
guidelines is CORRECT? Answer: 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? Answer: 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? Answer: 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.
⩥ What advice should the regulatory professional give a clinical trial
sponsor on the content required for the label on a study drug? Answer:
For sites in the EU, the labeling must specify the period of use for the
product.
⩥ A clinical investigator would like to use an investigational medicinal
product to treat a gravely ill patient who does not meet the protocol
inclusion criteria. However, in the expert opinion of the clinical
investigator, the product would be the best option for that patient. What
action is MOST appropriate for the clinical investigator to take? Answer:
Obtain approval from the CA for compassionate use of the product for
this particular patient.
⩥ A variation for a complex manufacturing change should include which
of the following? Answer: An expert statement and CV from a quality
expert.
