RAC DRUGS PRACTICE EXAM PREP
QUESTIONS WITH VERIFIED ANSWERS NEW
UPDATE
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
--ANSWER--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.
Page 1 of 70
,--ANSWER--3. Demonstrate bioequivalence between the innovator drug and
the proposed generic drug
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
--ANSWER--3. CDRH
During the review of a company's NDA submission by the FDA, a new
guideline is released by the FDA that affects the labeling requirements for the
product. What should the regulatory professional do in response to this change?
1. Revise the labeling immediately and resubmit to the FDA.
2. Document the change and address it in the next annual report.
3. Ignore the guideline as the NDA is already under review.
Page 2 of 70
,4. Consult with the FDA to determine if a supplemental submission is
necessary.
--ANSWER--4. Consult with the FDA to determine if a supplemental
submission is necessary.
A company is developing an unapproved cell and gene therapy that is a
combination product (device-biologic). What application and to which center
should the company submit its application for marketing approval?
1. Submit a Premarket Notification application to CDRH.
2. Submit a Biologic License Application (BLA) to CDER
3. Submit a BLA to CBER
4. Submit an Investigational New Drug Application (IND) tp CBER
--ANSWER--3. Submit a Biologic License Application to CBER
Which of the following labeling elements is NOT required for all over-the-
counter drugs in the U.S.?
1. Name and place of business of manufacturer, packer, or distributor?
2. Net quantity of contents.
3. Statement of ingredients
Page 3 of 70
, 4. Pregnancy/breast-feeding warning.
--ANSWER--1. Name and place of business of manufacturer, packer, or
distributor?
Which of the following is not classified as an "Off-label" use:
1. A patient is prescribed an approved drug that was deemed safe and effective
for a different disease indication.
2. A patient is prescribed an approved drug at a different dosage other than the
approved label.
3. A patient is prescribed a drug that was approved as a capsule but was
prescribed as an oral solution.
4. A patient was prescribed an approved drug per the label; however, the drug
was a generic instead of the brand name.
--ANSWER--4. A patient was prescribed an approved drug per the label;
however, the drug was a generic instead of the brand name.
After submitting an NDA for a new drug, what is the latest timeframe for a
company to pro vide the FDA with a safety update report to prevent an
extension of the review period?
1. Three months after the NDA submission (90 day safety update)
Page 4 of 70
QUESTIONS WITH VERIFIED ANSWERS NEW
UPDATE
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
--ANSWER--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.
Page 1 of 70
,--ANSWER--3. Demonstrate bioequivalence between the innovator drug and
the proposed generic drug
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
--ANSWER--3. CDRH
During the review of a company's NDA submission by the FDA, a new
guideline is released by the FDA that affects the labeling requirements for the
product. What should the regulatory professional do in response to this change?
1. Revise the labeling immediately and resubmit to the FDA.
2. Document the change and address it in the next annual report.
3. Ignore the guideline as the NDA is already under review.
Page 2 of 70
,4. Consult with the FDA to determine if a supplemental submission is
necessary.
--ANSWER--4. Consult with the FDA to determine if a supplemental
submission is necessary.
A company is developing an unapproved cell and gene therapy that is a
combination product (device-biologic). What application and to which center
should the company submit its application for marketing approval?
1. Submit a Premarket Notification application to CDRH.
2. Submit a Biologic License Application (BLA) to CDER
3. Submit a BLA to CBER
4. Submit an Investigational New Drug Application (IND) tp CBER
--ANSWER--3. Submit a Biologic License Application to CBER
Which of the following labeling elements is NOT required for all over-the-
counter drugs in the U.S.?
1. Name and place of business of manufacturer, packer, or distributor?
2. Net quantity of contents.
3. Statement of ingredients
Page 3 of 70
, 4. Pregnancy/breast-feeding warning.
--ANSWER--1. Name and place of business of manufacturer, packer, or
distributor?
Which of the following is not classified as an "Off-label" use:
1. A patient is prescribed an approved drug that was deemed safe and effective
for a different disease indication.
2. A patient is prescribed an approved drug at a different dosage other than the
approved label.
3. A patient is prescribed a drug that was approved as a capsule but was
prescribed as an oral solution.
4. A patient was prescribed an approved drug per the label; however, the drug
was a generic instead of the brand name.
--ANSWER--4. A patient was prescribed an approved drug per the label;
however, the drug was a generic instead of the brand name.
After submitting an NDA for a new drug, what is the latest timeframe for a
company to pro vide the FDA with a safety update report to prevent an
extension of the review period?
1. Three months after the NDA submission (90 day safety update)
Page 4 of 70
