RAC DRUGS PRACTICE EXAM 2024-2025 /COMPLETE ACTUAL EXAM
QUESTIONS AND CORRECT ANSWERS (VERIFIED ANSWERS )
A GRADED.
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?
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."
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 Read
More
,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.
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
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
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.
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.
5. No action is required since it is an off-label use. clinicians have the freedom
to treat their patients based on what is medically appropriate.
2. Discuss with regulatory authorities to investigate how to have the off-label
indication approved.
In the EU, which type of documentation should NOT be included in Module 1
of a submitted dossier?
1. SmPC, Labeling, and Package leaflet.
2. Environmental Risk Assessment.
3. Quality overall summary
4. Risk management plan
3. Quality Overall Summary
To obtain approval for an ANDA, a company MUST meet which criterion?
1. Submit and receive approval for an IND
2. Demonstrate safety and efficacy of the proposed generic drug
3. Demonstrate bioequivalence between the innovator drug and the proposed
generic drug.
4. Demonstrate the efficacy of the innovator drug and the proposed generic.
3. Demonstrate bioequivalence between the innovator drug and the proposed
generic drug
QUESTIONS AND CORRECT ANSWERS (VERIFIED ANSWERS )
A GRADED.
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?
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."
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 Read
More
,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.
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
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
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.
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.
5. No action is required since it is an off-label use. clinicians have the freedom
to treat their patients based on what is medically appropriate.
2. Discuss with regulatory authorities to investigate how to have the off-label
indication approved.
In the EU, which type of documentation should NOT be included in Module 1
of a submitted dossier?
1. SmPC, Labeling, and Package leaflet.
2. Environmental Risk Assessment.
3. Quality overall summary
4. Risk management plan
3. Quality Overall Summary
To obtain approval for an ANDA, a company MUST meet which criterion?
1. Submit and receive approval for an IND
2. Demonstrate safety and efficacy of the proposed generic drug
3. Demonstrate bioequivalence between the innovator drug and the proposed
generic drug.
4. Demonstrate the efficacy of the innovator drug and the proposed generic.
3. Demonstrate bioequivalence between the innovator drug and the proposed
generic drug
