RAC EXAM REVIEW 2026 DETAILED
QUESTIONS AND SOLVED SOLUTIONS
◉What is the MINIMUM time in months of continuous use that
mandates carcinogenicity testing for pharmaceuticals? Answer: 6
◉If there is a slight change in the drug substance storage
temperature, for instance, from - 16°C ± 4°C to - 20°C ± 5°C, would
you submit the change to the health authority? Answer: Yes, submit
with required documents and rationale letter.
◉In order to develop a global drug product, what is the MOST
important environmental characteristic to consider in the country of
intended use? Answer: Product stability
◉In what module of the CTD is information on the quality of a
medicinal product noted? Answer: 2
◉A company is developing a new chemical entity. As part of the
preclinical investigations, which of the following battery of toxicity
tests cannot be waived and MUST be completed? Answer:
Genotoxicity
,◉The safety database for an anti-hypertensive drug consists of the
following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data
requirement has NOT been met? Answer: 100 patients for 12
months
◉Which of the following would FDA consider to be obstructing an
inspection? Answer: The facility fails to produce requested records
in a timely manner, without a reasonable explanation.
◉Which of the following is directly related to the stability of a
product? Answer: Expiration date
◉Dextromethorphan, an over-the-counter cough suppressant, has
been subject to WHO discussions about scheduling as a controlled
substance due to its psychoactive effects and potential for severe
psychological dependence. Which of the below would you
recommend as an argument against scheduling? Answer: Strategies
other than scheduling would preserve access while reducing abuse.
, ◉Which of the following is false regarding meeting minutes for
formal meetings relating to biological products regulated by CBER?
Answer: For input on additional issues not addressed at the meeting,
the requester should submit a response to the FDA meeting minutes.
◉A specification deviation occurred on seven batches of a
pharmaceutical product that could lead to a product recall. In which
of the following activities is the regulatory professional MOST
closely involved? Answer: Developing a recall strategy.
◉In its Guidance, Regulatory Considerations for Human Cells,
Tissues, and Cellular and Tissue-Based Products: Minimal
Manipulation and Homologous Use, issued in November 2017 and
updated in July 2020, FDA announced a compliance and
enforcement discretion policy to give manufacturers time to
determine if they need to submit an IND or marketing application.
This policy ended in May 2021. Answer: FDA will comment, if
requested, on its compliance or enforcement approach in light of
this policy change.
◉Which of the following changes to a drug product is MOST likely to
be implemented without prior regulatory authority approval?
Answer: Strengthening a precaution to the product labeling.
QUESTIONS AND SOLVED SOLUTIONS
◉What is the MINIMUM time in months of continuous use that
mandates carcinogenicity testing for pharmaceuticals? Answer: 6
◉If there is a slight change in the drug substance storage
temperature, for instance, from - 16°C ± 4°C to - 20°C ± 5°C, would
you submit the change to the health authority? Answer: Yes, submit
with required documents and rationale letter.
◉In order to develop a global drug product, what is the MOST
important environmental characteristic to consider in the country of
intended use? Answer: Product stability
◉In what module of the CTD is information on the quality of a
medicinal product noted? Answer: 2
◉A company is developing a new chemical entity. As part of the
preclinical investigations, which of the following battery of toxicity
tests cannot be waived and MUST be completed? Answer:
Genotoxicity
,◉The safety database for an anti-hypertensive drug consists of the
following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data
requirement has NOT been met? Answer: 100 patients for 12
months
◉Which of the following would FDA consider to be obstructing an
inspection? Answer: The facility fails to produce requested records
in a timely manner, without a reasonable explanation.
◉Which of the following is directly related to the stability of a
product? Answer: Expiration date
◉Dextromethorphan, an over-the-counter cough suppressant, has
been subject to WHO discussions about scheduling as a controlled
substance due to its psychoactive effects and potential for severe
psychological dependence. Which of the below would you
recommend as an argument against scheduling? Answer: Strategies
other than scheduling would preserve access while reducing abuse.
, ◉Which of the following is false regarding meeting minutes for
formal meetings relating to biological products regulated by CBER?
Answer: For input on additional issues not addressed at the meeting,
the requester should submit a response to the FDA meeting minutes.
◉A specification deviation occurred on seven batches of a
pharmaceutical product that could lead to a product recall. In which
of the following activities is the regulatory professional MOST
closely involved? Answer: Developing a recall strategy.
◉In its Guidance, Regulatory Considerations for Human Cells,
Tissues, and Cellular and Tissue-Based Products: Minimal
Manipulation and Homologous Use, issued in November 2017 and
updated in July 2020, FDA announced a compliance and
enforcement discretion policy to give manufacturers time to
determine if they need to submit an IND or marketing application.
This policy ended in May 2021. Answer: FDA will comment, if
requested, on its compliance or enforcement approach in light of
this policy change.
◉Which of the following changes to a drug product is MOST likely to
be implemented without prior regulatory authority approval?
Answer: Strengthening a precaution to the product labeling.
