RAC DRUGS PRACTICE EXAM 2025
RAC DRUGS PRACTICE EXAM 2025 WITH GUARANTEED ACCURATE ANSWERS
One month prior to the anticipated approval date for your product, the
marketing application that you submitted to a major regulatory authority
has become the subject of an advisory committee meeting of experts
convened by the regulatory authority. The advisory committee members
unanimously vote not to approve your product because of a safety
concern. Two days after the advisory committee meeting, the regulatory
authority requests additional information to support the safety of your
product. Assuming you have no additional data to provide, which of the
following would be your MOST appropriate response to the regulatory
authority's request? - ACCURATE ANSWERS✔✔ See next card
1. "Given the advisory committee's unanimous decision, we know that
the product will not be approved, and additional data will not make any
difference.
,2. "We have no additional information to provide at this time, but we can
perform an additional analysis for a specific safety concern, if
necessary."
3. "We disagree with the advisory committee's decision because the
committee neglected the thorough safety analysis that we provided."
4. "We have no additional information to provide at this time because we
have already provided everything needed to support our product's
approval." - ACCURATE ANSWERS✔✔ 2. We have no additional
information to provide at this time, but we can perform an additional
analysis for a specific safety concern, if necessary
Which of the following responsibilities is specifically assigned to the
Qualified Person (QP) during the batch release process?
1. The QP must ensure that all manufacturing processes are completed
before batch release.
2. The QP is tasked with verifying that the batch meets the specifications
outlined in the Marketing Authorization.
3. The QP is responsible for conducting clinical trials for the product.
4. The QP must oversee the marketing strategies for the product. -
ACCURATE ANSWERS✔✔ 2. The QP is tasked with verifying that the
batch meets the specifications outlined in the Marketing Authorization
What is the required duration of continuous administration in months
that necessitates the evaluation of carcinogenic potential for
pharmaceutical products?
,1. 3 moths
2. 6 months
3. 12 months
4. 24 months - ACCURATE ANSWERS✔✔ 2. 6 months
A sponsor is planning to initiate a pivotal clinical study for a drug-lead
combination product (e.g. prefilled syringe, autoinjector, etc.). For the
device constituent of the combination product, what's the FDA minimum
regulatory requirement that must be met prior to introducing the
combination product into the clinical study?
1. Meet combination product cGMP requirements
2. Meet the usability human factors requirement.
3. Meet the design controls requirement according to 21 CFR part
820.30, unless the device constituent is exempt from design controls
requirements.
4. Meet the EU MDR General Safety and Performance - ACCURATE
ANSWERS✔✔ 3. Meet the design controls requirement according to 21
CFR Part 820.30, unless the device constituent is exempt from design
controls requirements.
Which of the following is false regarding FDA expedited programs?
, 1. The level of evidence required for Fast Track Designation is less than
for Breakthrough Therapy Designation?
2. Breakthrough Therapy Designation and RMAT Designation require
evidence that the drug may offer a substantial improvement relative to
available therapies.
3. RMAT Designation should be requested with the IND or later, but no
later than the EOP2 meeting.
4. Fast Track Designation, Breakthrough Therapy Designation, and
RMAT Designation may be rescinded later in product development. -
ACCURATE ANSWERS✔✔ 2. Breakthrough Therapy Designation and
RMAT Designation require evidence that the drug may offer a
substantial improvement relative to available therapies.
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?
1. file a report to regulatory authorities and advise the marketing
department to prevent future off-label use.
2. Discuss with regulatory authorities to investigate how to have the off-
label indication approved.
3. Discuss the off-label use with Key Opinion leaders (KOLs) to
determine how many patients would benefit from the approval of the
drug.
RAC DRUGS PRACTICE EXAM 2025 WITH GUARANTEED ACCURATE ANSWERS
One month prior to the anticipated approval date for your product, the
marketing application that you submitted to a major regulatory authority
has become the subject of an advisory committee meeting of experts
convened by the regulatory authority. The advisory committee members
unanimously vote not to approve your product because of a safety
concern. Two days after the advisory committee meeting, the regulatory
authority requests additional information to support the safety of your
product. Assuming you have no additional data to provide, which of the
following would be your MOST appropriate response to the regulatory
authority's request? - ACCURATE ANSWERS✔✔ See next card
1. "Given the advisory committee's unanimous decision, we know that
the product will not be approved, and additional data will not make any
difference.
,2. "We have no additional information to provide at this time, but we can
perform an additional analysis for a specific safety concern, if
necessary."
3. "We disagree with the advisory committee's decision because the
committee neglected the thorough safety analysis that we provided."
4. "We have no additional information to provide at this time because we
have already provided everything needed to support our product's
approval." - ACCURATE ANSWERS✔✔ 2. We have no additional
information to provide at this time, but we can perform an additional
analysis for a specific safety concern, if necessary
Which of the following responsibilities is specifically assigned to the
Qualified Person (QP) during the batch release process?
1. The QP must ensure that all manufacturing processes are completed
before batch release.
2. The QP is tasked with verifying that the batch meets the specifications
outlined in the Marketing Authorization.
3. The QP is responsible for conducting clinical trials for the product.
4. The QP must oversee the marketing strategies for the product. -
ACCURATE ANSWERS✔✔ 2. The QP is tasked with verifying that the
batch meets the specifications outlined in the Marketing Authorization
What is the required duration of continuous administration in months
that necessitates the evaluation of carcinogenic potential for
pharmaceutical products?
,1. 3 moths
2. 6 months
3. 12 months
4. 24 months - ACCURATE ANSWERS✔✔ 2. 6 months
A sponsor is planning to initiate a pivotal clinical study for a drug-lead
combination product (e.g. prefilled syringe, autoinjector, etc.). For the
device constituent of the combination product, what's the FDA minimum
regulatory requirement that must be met prior to introducing the
combination product into the clinical study?
1. Meet combination product cGMP requirements
2. Meet the usability human factors requirement.
3. Meet the design controls requirement according to 21 CFR part
820.30, unless the device constituent is exempt from design controls
requirements.
4. Meet the EU MDR General Safety and Performance - ACCURATE
ANSWERS✔✔ 3. Meet the design controls requirement according to 21
CFR Part 820.30, unless the device constituent is exempt from design
controls requirements.
Which of the following is false regarding FDA expedited programs?
, 1. The level of evidence required for Fast Track Designation is less than
for Breakthrough Therapy Designation?
2. Breakthrough Therapy Designation and RMAT Designation require
evidence that the drug may offer a substantial improvement relative to
available therapies.
3. RMAT Designation should be requested with the IND or later, but no
later than the EOP2 meeting.
4. Fast Track Designation, Breakthrough Therapy Designation, and
RMAT Designation may be rescinded later in product development. -
ACCURATE ANSWERS✔✔ 2. Breakthrough Therapy Designation and
RMAT Designation require evidence that the drug may offer a
substantial improvement relative to available therapies.
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?
1. file a report to regulatory authorities and advise the marketing
department to prevent future off-label use.
2. Discuss with regulatory authorities to investigate how to have the off-
label indication approved.
3. Discuss the off-label use with Key Opinion leaders (KOLs) to
determine how many patients would benefit from the approval of the
drug.
