Page 1 of 513
1
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RAC-DRUGS FINAL EXAM test 1
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.
2
,Page 3 of 513
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may be rescinded later in product development.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.
3
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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
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."
4
1
,Page 2 of 513
RAC-DRUGS FINAL EXAM test 1
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.
2
,Page 3 of 513
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.
3
, Page 4 of 513
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
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."
4
