RAC DRUGS EXAM |ACTUAL QUESTIONS AND
VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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.
CORRECT ANSWER
2. The QP is tasked with verifying that the batch meets the specifications outlined in the
Marketing Authorization
Question 2
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
CORRECT ANSWER
2. 6 months
1
,Question 3
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
CORRECT ANSWER
3. Meet the design controls requirement according to 21 CFR Part 820.30, unless the
device constituent is exempt from design controls requirements.
Question 4
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rescinded later in product development.
CORRECT ANSWER
2
, 2. Breakthrough Therapy Designation and RMAT Designation require evidence that the
drug may offer a substantial improvement relative to available therapies.
Question 5
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.
CORRECT ANSWER
2. Discuss with regulatory authorities to investigate how to have the off-label indication
approved.
Question 6
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
3
, 4. Risk management plan
CORRECT ANSWER
3. Quality Overall Summary
Question 7
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.
CORRECT ANSWER
3. Demonstrate bioequivalence between the innovator drug and the proposed generic
drug
Question 8
A firm is preparing a 501(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine a blood
donor's hematocrit prior to donation. The firm should address the 501(k) submission to:
1. CDER
2. CBER
3. CDRH
4. OCP
CORRECT ANSWER
3. CDRH
4
VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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.
CORRECT ANSWER
2. The QP is tasked with verifying that the batch meets the specifications outlined in the
Marketing Authorization
Question 2
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
CORRECT ANSWER
2. 6 months
1
,Question 3
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
CORRECT ANSWER
3. Meet the design controls requirement according to 21 CFR Part 820.30, unless the
device constituent is exempt from design controls requirements.
Question 4
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.
CORRECT ANSWER
2
, 2. Breakthrough Therapy Designation and RMAT Designation require evidence that the
drug may offer a substantial improvement relative to available therapies.
Question 5
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.
CORRECT ANSWER
2. Discuss with regulatory authorities to investigate how to have the off-label indication
approved.
Question 6
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
3
, 4. Risk management plan
CORRECT ANSWER
3. Quality Overall Summary
Question 7
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.
CORRECT ANSWER
3. Demonstrate bioequivalence between the innovator drug and the proposed generic
drug
Question 8
A firm is preparing a 501(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine a blood
donor's hematocrit prior to donation. The firm should address the 501(k) submission to:
1. CDER
2. CBER
3. CDRH
4. OCP
CORRECT ANSWER
3. CDRH
4
