RAC Exam practice Questions with
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A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90%
confidence intervals for the ratio of population geometric means between the two treatments based on
log-transformed data is contained within the equivalence limits of ____% - ____% for AUC and Cmax. a)
80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - Answer -D: 80% and 125%
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to multiple sites. Which
of the following statements are true? a) Each contract facility must be listed in its own establishment
license application (ELA). b) Each contract facility must be listed in the BLA. c) Each contract facility must
appear in the product labeling. d) Each contract facility must take responsibility for compliance with
applicable establishment and product requirements for biologics. e) b and d f) All of the above(22:1) -
Answer -e) b:Each contract facility must be listed in the BLA and d: Each contract facility must take
responsibility for compliance with applicable establishment and product requirements for biologics.
A Special 510(k) relies on the following information: a) Design control documentation b) Guidance
documents c) Consensus standards d) All of the above(2:6) - Answer -A: Design control
documentation
According to the regulations under 21 CFR 3 PMOA is defined as: a) "the simplest action of a product
that provides the most important therapeutic action of the combination product" b) "the basic
therapeutic action of a combination product that provides the most important intended use" c) "the
single mode of action of a combination product that provides the most important therapeutic action of
the combination product" d) "the modes of activity of a combination product that act the most
important intended use of the combination product" e) None of the above(25:4) - Answer -c) "the
single mode of action of a combination product that provides the most important therapeutic action of
the combination product"
Although FDA's statutory authority does not extend to the occupational safety and health responsibilities
of OSHA the agencies coordinate their efforts in matters of related responsibility such as unshielded
syringes and natural rubber latex. True or False?(2:2) - Answer -True
An FDA investigator / inspector should review the following when inspecting the different processes of a
blood donation center: a) the accuracy availability and appropriateness of procedures b) personnel are
qualified trained and adequate in number for the operations c) the facility is appropriate for the
operations adequately maintained d) equipment is maintained in a manner to ensure it will perform as
intended e) records are maintained such that each step can be traced and provided a complete history of
work performed f) all of the above.(27:5) - Answer -f) all of the above.
, An FDA petition much contain which of the following? a) Action requested b) Statement of grounds c)
Environmental impact d) All of the above(2:3) - Answer -D: All of the above
An independent peer-reviewed journal article on an off-label use of an approved biologic may be
disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0
days f) 30 days g) 60 days h) 3 months(24:3) - Answer -g) 60 days
Biological products are approved for marketing under provisions of: a) Food Drug and Cosmetic Act b)
Acceptable GMP inspection c) Public Heath Service Act d) a and be) All of the above(22:3) -
Answer -e) all of the above
Biologics are cleared for marketing through which process ?a) Establishment License Application (ELA)b)
Product License Application (PLA)c) Biologics License Application (BLA)d) All of the above(2:5) -
Answer -C: Biologics License Application (BLA)
Both regulations and guidance documents have the force of law. True or False?(2:1) - Answer -
False. Only regulations have the force of law.
clinical trial. - Answer -
Corrections to the signed and dated final study report may be made in the form of a report amendment
by the: a) Quality Assurance Unit b) Test Facility Management c) Study Directory d) Any of the above e)
None of the above(6:5) - Answer -C: Study Director
Devices could be misbranded for: a) not providing adequate directions for use b) not stating
performance claims for the device c) not providing enough information on the risks d) a and c e) a b and
c(20:4) - Answer -e) a(not providing adequate directions for use) b(not stating performance claims
for the device) and c(not providing enough information on the risks)
Does the clinical trial database apply to drugs or devices? (8:2) - Answer -Drugs
Does the Quality System Regulation apply to drugs or devices?(8:1) - Answer -Devices
Drugs may be eligible for over-the-counter status when: a) They have been marketed to a material extent
b) They have been marketed for a material time c) Are generally recognized as safe d) All of the
above(2:4) - Answer -D: All of the above
FDA and FTC share responsibilities in regulating healthcare products. FDA has authority over labeling
plus: a) the advertising of OTC drugs b) the advertising or prescription drugs c) the advertising of
restricted devices d) a and be) b and c(20:1) - Answer -e) b(the advertising or prescription drugs)
and c(the advertising of restricted devices)
FDA approved labeling is part of the submission process with: a) PMA 510(k) b) PMA BLA and NDA c)
PMA and IDE d) ASR 510(k) and PMA(20:5) - Answer -b) PMA BLA and NDA
FDA interprets its regulatory authority over labeling to include: a) Bottle labels b) Package inserts c)
Medication Guides d) Promotional materials e) a b and c f) a b c and d(17:1) - Answer -f) a (bottle
labels) b (Package inserts) c (Medication Guides) and d (Promotional materials)
Correct Answers Graded A Download to
get A perfect Score
A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90%
confidence intervals for the ratio of population geometric means between the two treatments based on
log-transformed data is contained within the equivalence limits of ____% - ____% for AUC and Cmax. a)
80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - Answer -D: 80% and 125%
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to multiple sites. Which
of the following statements are true? a) Each contract facility must be listed in its own establishment
license application (ELA). b) Each contract facility must be listed in the BLA. c) Each contract facility must
appear in the product labeling. d) Each contract facility must take responsibility for compliance with
applicable establishment and product requirements for biologics. e) b and d f) All of the above(22:1) -
Answer -e) b:Each contract facility must be listed in the BLA and d: Each contract facility must take
responsibility for compliance with applicable establishment and product requirements for biologics.
A Special 510(k) relies on the following information: a) Design control documentation b) Guidance
documents c) Consensus standards d) All of the above(2:6) - Answer -A: Design control
documentation
According to the regulations under 21 CFR 3 PMOA is defined as: a) "the simplest action of a product
that provides the most important therapeutic action of the combination product" b) "the basic
therapeutic action of a combination product that provides the most important intended use" c) "the
single mode of action of a combination product that provides the most important therapeutic action of
the combination product" d) "the modes of activity of a combination product that act the most
important intended use of the combination product" e) None of the above(25:4) - Answer -c) "the
single mode of action of a combination product that provides the most important therapeutic action of
the combination product"
Although FDA's statutory authority does not extend to the occupational safety and health responsibilities
of OSHA the agencies coordinate their efforts in matters of related responsibility such as unshielded
syringes and natural rubber latex. True or False?(2:2) - Answer -True
An FDA investigator / inspector should review the following when inspecting the different processes of a
blood donation center: a) the accuracy availability and appropriateness of procedures b) personnel are
qualified trained and adequate in number for the operations c) the facility is appropriate for the
operations adequately maintained d) equipment is maintained in a manner to ensure it will perform as
intended e) records are maintained such that each step can be traced and provided a complete history of
work performed f) all of the above.(27:5) - Answer -f) all of the above.
, An FDA petition much contain which of the following? a) Action requested b) Statement of grounds c)
Environmental impact d) All of the above(2:3) - Answer -D: All of the above
An independent peer-reviewed journal article on an off-label use of an approved biologic may be
disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0
days f) 30 days g) 60 days h) 3 months(24:3) - Answer -g) 60 days
Biological products are approved for marketing under provisions of: a) Food Drug and Cosmetic Act b)
Acceptable GMP inspection c) Public Heath Service Act d) a and be) All of the above(22:3) -
Answer -e) all of the above
Biologics are cleared for marketing through which process ?a) Establishment License Application (ELA)b)
Product License Application (PLA)c) Biologics License Application (BLA)d) All of the above(2:5) -
Answer -C: Biologics License Application (BLA)
Both regulations and guidance documents have the force of law. True or False?(2:1) - Answer -
False. Only regulations have the force of law.
clinical trial. - Answer -
Corrections to the signed and dated final study report may be made in the form of a report amendment
by the: a) Quality Assurance Unit b) Test Facility Management c) Study Directory d) Any of the above e)
None of the above(6:5) - Answer -C: Study Director
Devices could be misbranded for: a) not providing adequate directions for use b) not stating
performance claims for the device c) not providing enough information on the risks d) a and c e) a b and
c(20:4) - Answer -e) a(not providing adequate directions for use) b(not stating performance claims
for the device) and c(not providing enough information on the risks)
Does the clinical trial database apply to drugs or devices? (8:2) - Answer -Drugs
Does the Quality System Regulation apply to drugs or devices?(8:1) - Answer -Devices
Drugs may be eligible for over-the-counter status when: a) They have been marketed to a material extent
b) They have been marketed for a material time c) Are generally recognized as safe d) All of the
above(2:4) - Answer -D: All of the above
FDA and FTC share responsibilities in regulating healthcare products. FDA has authority over labeling
plus: a) the advertising of OTC drugs b) the advertising or prescription drugs c) the advertising of
restricted devices d) a and be) b and c(20:1) - Answer -e) b(the advertising or prescription drugs)
and c(the advertising of restricted devices)
FDA approved labeling is part of the submission process with: a) PMA 510(k) b) PMA BLA and NDA c)
PMA and IDE d) ASR 510(k) and PMA(20:5) - Answer -b) PMA BLA and NDA
FDA interprets its regulatory authority over labeling to include: a) Bottle labels b) Package inserts c)
Medication Guides d) Promotional materials e) a b and c f) a b c and d(17:1) - Answer -f) a (bottle
labels) b (Package inserts) c (Medication Guides) and d (Promotional materials)
