RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
1. One month prior to the an- See next card
ticipated approval date for
your product, the market-
ing application that you sub-
mitted to a major regulato-
ry authority has become the
subject of an advisory com-
mittee meeting of experts
convened by the regulato-
ry authority. The advisory
committee members unani-
mously vote not to approve
your product because of a
safety concern. Two days af-
ter the advisory committee
meeting, the regulatory au-
thority requests additional
information to support the
safety of your product. As-
suming you have no addi-
tional data to provide, which
of the following would be
your MOST appropriate re-
sponse to the regulatory au-
thority's request?
2. 1. "Given the advisory com- 2. We have no additional information to provide at this time,
mittee's unanimous deci- but we can perform an additional analysis for a specific safety
sion, we know that the prod- concern, if necessary
uct will not be approved,
and additional data will not
make any difference.
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
2. "We have no additional in-
formation to provide at this
time, but we can perform an
additional analysis for a spe-
cific safety concern, if neces-
sary."
3. "We disagree with the ad-
visory committee's decision
because the committee ne-
glected the thorough safety
analysis that we provided."
4. "We have no addition-
al information to provide at
this time because we have
already provided everything
needed to support our prod-
uct's approval."
3. Which of the following re- 2. The QP is tasked with verifying that the batch meets the spec-
sponsibilities is specifical- ifications outlined in the Marketing Authorization
ly assigned to the Quali-
fied 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 ver-
ifying that the batch meets
the specifications outlined
in the Marketing Authoriza-
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
tion.
3. The QP is responsible for
conducting clinical trials for
the product.
4. The QP must oversee the
marketing strategies for the
product.
4. What is the required dura- 2. 6 months
tion of continuous adminis-
tration in months that ne-
cessitates the evaluation of
carcinogenic potential for
pharmaceutical products?
1. 3 moths
2. 6 months
3. 12 months
4. 24 months
5. A sponsor is planning to ini- 3. Meet the design controls requirement according to 21 CFR
tiate a pivotal clinical study Part 820.30, unless the device constituent is exempt from design
for a drug-lead combina- controls requirements.
tion product (e.g. prefilled
syringe, autoinjector, etc.).
For the device constituent
of the combination prod-
uct, what's the FDA min-
imum regulatory require-
ment that must be met prior
to introducing the combina-
tion product into the clinical
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
study?
1. Meet combination prod-
uct cGMP requirements
2. Meet the usability human
factors requirement.
3. Meet the design con-
trols requirement according
to 21 CFR part 820.30, unless
the device constituent is ex-
empt from design controls
requirements.
4. Meet the EU MDR General
Safety and Performance
6. Which of the following is 2. Breakthrough Therapy Designation and RMAT Designation re-
false regarding FDA expedit- quire evidence that the drug may otter a substantial improvement
ed programs? relative to available therapies.
1. The level of evidence re-
quired for Fast Track Desig-
nation is less than for Break-
through Therapy Designa-
tion?
2. Breakthrough Therapy
Designation and RMAT Des-
ignation require evidence
that the drug may offer
a substantial improvement
relative to available thera-
pies.
3. RMAT Designation should
Regulatory Affairs Certification Exam
1. One month prior to the an- See next card
ticipated approval date for
your product, the market-
ing application that you sub-
mitted to a major regulato-
ry authority has become the
subject of an advisory com-
mittee meeting of experts
convened by the regulato-
ry authority. The advisory
committee members unani-
mously vote not to approve
your product because of a
safety concern. Two days af-
ter the advisory committee
meeting, the regulatory au-
thority requests additional
information to support the
safety of your product. As-
suming you have no addi-
tional data to provide, which
of the following would be
your MOST appropriate re-
sponse to the regulatory au-
thority's request?
2. 1. "Given the advisory com- 2. We have no additional information to provide at this time,
mittee's unanimous deci- but we can perform an additional analysis for a specific safety
sion, we know that the prod- concern, if necessary
uct will not be approved,
and additional data will not
make any difference.
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
2. "We have no additional in-
formation to provide at this
time, but we can perform an
additional analysis for a spe-
cific safety concern, if neces-
sary."
3. "We disagree with the ad-
visory committee's decision
because the committee ne-
glected the thorough safety
analysis that we provided."
4. "We have no addition-
al information to provide at
this time because we have
already provided everything
needed to support our prod-
uct's approval."
3. Which of the following re- 2. The QP is tasked with verifying that the batch meets the spec-
sponsibilities is specifical- ifications outlined in the Marketing Authorization
ly assigned to the Quali-
fied 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 ver-
ifying that the batch meets
the specifications outlined
in the Marketing Authoriza-
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
tion.
3. The QP is responsible for
conducting clinical trials for
the product.
4. The QP must oversee the
marketing strategies for the
product.
4. What is the required dura- 2. 6 months
tion of continuous adminis-
tration in months that ne-
cessitates the evaluation of
carcinogenic potential for
pharmaceutical products?
1. 3 moths
2. 6 months
3. 12 months
4. 24 months
5. A sponsor is planning to ini- 3. Meet the design controls requirement according to 21 CFR
tiate a pivotal clinical study Part 820.30, unless the device constituent is exempt from design
for a drug-lead combina- controls requirements.
tion product (e.g. prefilled
syringe, autoinjector, etc.).
For the device constituent
of the combination prod-
uct, what's the FDA min-
imum regulatory require-
ment that must be met prior
to introducing the combina-
tion product into the clinical
, RAC Drugs Practice Exam 2025-2026
Regulatory Affairs Certification Exam
study?
1. Meet combination prod-
uct cGMP requirements
2. Meet the usability human
factors requirement.
3. Meet the design con-
trols requirement according
to 21 CFR part 820.30, unless
the device constituent is ex-
empt from design controls
requirements.
4. Meet the EU MDR General
Safety and Performance
6. Which of the following is 2. Breakthrough Therapy Designation and RMAT Designation re-
false regarding FDA expedit- quire evidence that the drug may otter a substantial improvement
ed programs? relative to available therapies.
1. The level of evidence re-
quired for Fast Track Desig-
nation is less than for Break-
through Therapy Designa-
tion?
2. Breakthrough Therapy
Designation and RMAT Des-
ignation require evidence
that the drug may offer
a substantial improvement
relative to available thera-
pies.
3. RMAT Designation should
