RAC Practice exam 2 -HJ 2025–2026 Accurate
Real Exam Questions and Verified Correct
Answers
A company is developing a combination product consisting of a device that injects a specially
formulated small molecule drug for pain into the muscle tissue. Which of the following describes
the best US regulatory path:
A. The product is regulated as a drug
B. The product is regulated under CDRH
C. The company should file a BLA to obtain US marketing approval
D. The company should submit a request for designation to OCP - answer>>>A.
21 CFR 3.4 (http://edocket.access.gpo.gov/cfr_2008/aprqtr/21cfr3.4.htm) is the regulation
regarding how FDA designates combination product review. Designation of the lead FDA review
center is based on the product's Primary Mode of Action (PMOA). FDA issued a final rule on 25
August 2005 for the definition of PMOA.
Statutory provision regarding product classification and the Office of Combination Products' roles
and responsibilities can be found in FD&C Act Section 563
(http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct
/FDCActChapterVDrugsandDevices/ucm110768.htm). Question
Feedback
Primary mode of action is the pain drug and the device is a delivery system.
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labeling specifications
C. Design reviews
D. Calibration records - answer>>>B.
Labeling specifications are part of the DMR.
A Drug Master File may be used for any of the following purposes EXCEPT:
A. Supplemental information on the drug product or drug substance
B. Supplemental information for any type of submission to the agency
C. FDA approval of the Drug Master File
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,D. Incorporation by reference of all or part of any Drug Master File's contents to support a
submission when the holder has authorized the incorporation in writing - answer>>>C.
FDA does not approve or disapprove Drug Master Files; it only reviews them as supplemental
information.
Sec. 314.420 Drug master files.
FDA ordinarily neither independently reviews Drug Master Files nor approves or disapproves
submissions to a drug master file.
A company is evaluating next steps for a small Phase 1/2 clinical trial. Of four cohorts, the
company just has completed enrollment of the third. Immunology testing efficacy data have
revealed a small signal was detected. Based on these data; the company believes the fourth cohort
should be dosed with a higher concentration of drug product. The concentration required is higher
than the current drug product dose and may not be supported nonclinical toxicology studies. The
higher dose also will require additional product development and the manufacturing time is
estimated at approximately 18 months. What is the best regulatory approach?
A. Current clinical protocol recruitment should be put on hold for two years to await the new drug
product
B. The current clinical protocol should be terminated and a new clinical protocol written with new
dosing supported by nonclinical studies.
C. The clinical protocol should be ame - answer>>>B.
Trials that are inactive for two years are put on FDA inactive list
Good Manufacturing Practices (GMPs) are NOT applied to the chemical synthesis of an Active
Pharmaceutical Ingredient (API) manufacturing process during:
A. Intermediate compound drying
B. Introduction of the starting material into the process
C. Starting material synthesis
D. API Packaging - answer>>>C.
For synthetic processes, the introduction of the starting material into the manufacturing process is
known as the point at which GMPs are applied in API manufacture. Starting materials synthesis
does not have to be completed under GMPs.
Once an Investigational New Drug (IND) is in effect, an amendment can be submitted for all the
following EXCEPT:
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,A. The sponsor intends to conduct a clinical investigation with an exception from Informed
Consent for emergency research
B. A change in a Phase 3 protocol significantly affecting subjects' safety, the investigation's scope
or the study's scientific quality
C. Addition of a new investigator to carry out a previously submitted protocol
D. Submission of new toxicology, chemistry or other technical information, or a report regarding
the discontinuation of a clinical investigation - answer>>>A.
Whenever a sponsor intends to conduct a clinical investigation with an exception from Informed
Consent for emergency research as set forth in 21 CFR 50.24, the sponsor shall submit a separate
IND to FDA for such investigation. The other choices should be submitted as IND amendments.
Which of the following statements is TRUE for Phase 2 clinical investigations of a NCE?
A. They are designed to determine the metabolism and pharmacologic actions of the drug in
humans.
B. They are intended to gather additional information about effectiveness and safety to evaluate
the overall benefit-risk of the drug.
C. They are conducted to determine the common short-term side effects and risks associated with
the drug.
D. They are performed to provide an adequate basis for physician labeling. - answer>>>C.
Answer 3 is true for Phase 2 studies, answer 1 is true for Phase 1 studies and answers 2 and 4 are
true for Phase 3 studies.
Sponsors of a clinical trial must immediately notify FDA and investigators of serious adverse
events EXCEPT:
A. Temporally associated with the investigational item's use but are not serious and/or
unexpected
B. Described in the Investigator's Brochure but with greater severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the
drug - answer>>>A.
Events that are not undesirable are not adverse events. Events in animals are not reportable. Events
of greater severity than described in the Investigator's Brochure are unexpected and therefore
reportable.
According to 21 CFR 312.32:
Answer 2, unexpected fatal or life-threatening suspected adverse reactions, should be reported.
The sponsor also must notify FDA of any unexpected fatal or life- threatening suspected adverse
3|Page
, reaction as soon as possible, but in no case later than seven calendar days after the sponsor's initial
receipt of the information.
Additionally, according to the Guidance for Clinical Investigators, Sponsors and IRBs—Adverse Event
Reporting to IRBs—Improving Human Subject Protection:
An AE that is described or addressed in the Investigator's Brochure, protocol or informed consent
documents, but occurs at a specificity or severity inconsistent with prior
observations should be reported.
According to 21 CFR 312.32, answer ID 3, increased rate of occurrence of serious adverse reaction,
should be reported.
The sponsor must report any clinically important increase in the rate of a serious suspected adverse
reaction over than listed in the protocol or Investigator Brochure. According to 21 CFR 312.32,
answer ID 4, iii) findings coming from animal or in vitro testing, also should be reported. The
sponsor must report any findings from animal or in vitro testing, whether or not conducted by the
sponsor, that suggest a significant risk in humans exposed to the drug, such as mutagenicity,
teratogenicity or carcinogenicity reports, or reports of significant organ toxicity at or near the
expected human exposure.
Your company is making a change to a specification to comply with an official compendium of an
NDA product. How should this change be reported?
A. In a CBE-30 due to the moderate potential of the change to have an adverse effect
B. As an update in the next Annual Report
C. In a new letter of authorization
D. There is no need to report this change -
answer>>>B. Minor Changes (Annual Report)
The following are examples of changes in specifications considered to have a minimal potential to
have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as
these factors may relate to the safety or effectiveness of the drug product.
Any change in a specification made to comply with an official compendium, except the changes
described in section VIII.C.1.e, that is consistent with FDA statutory and regulatory requirements
(§ 314.70(d)(2)(i)).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM070621.pdf
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM070621.pdf)
For compendial drug products approved under an NDA or ANDA, changes made to the
specifications in the approved application regarding General Chapter <467> should be in
4|Page
Real Exam Questions and Verified Correct
Answers
A company is developing a combination product consisting of a device that injects a specially
formulated small molecule drug for pain into the muscle tissue. Which of the following describes
the best US regulatory path:
A. The product is regulated as a drug
B. The product is regulated under CDRH
C. The company should file a BLA to obtain US marketing approval
D. The company should submit a request for designation to OCP - answer>>>A.
21 CFR 3.4 (http://edocket.access.gpo.gov/cfr_2008/aprqtr/21cfr3.4.htm) is the regulation
regarding how FDA designates combination product review. Designation of the lead FDA review
center is based on the product's Primary Mode of Action (PMOA). FDA issued a final rule on 25
August 2005 for the definition of PMOA.
Statutory provision regarding product classification and the Office of Combination Products' roles
and responsibilities can be found in FD&C Act Section 563
(http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct
/FDCActChapterVDrugsandDevices/ucm110768.htm). Question
Feedback
Primary mode of action is the pain drug and the device is a delivery system.
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labeling specifications
C. Design reviews
D. Calibration records - answer>>>B.
Labeling specifications are part of the DMR.
A Drug Master File may be used for any of the following purposes EXCEPT:
A. Supplemental information on the drug product or drug substance
B. Supplemental information for any type of submission to the agency
C. FDA approval of the Drug Master File
1|Page
,D. Incorporation by reference of all or part of any Drug Master File's contents to support a
submission when the holder has authorized the incorporation in writing - answer>>>C.
FDA does not approve or disapprove Drug Master Files; it only reviews them as supplemental
information.
Sec. 314.420 Drug master files.
FDA ordinarily neither independently reviews Drug Master Files nor approves or disapproves
submissions to a drug master file.
A company is evaluating next steps for a small Phase 1/2 clinical trial. Of four cohorts, the
company just has completed enrollment of the third. Immunology testing efficacy data have
revealed a small signal was detected. Based on these data; the company believes the fourth cohort
should be dosed with a higher concentration of drug product. The concentration required is higher
than the current drug product dose and may not be supported nonclinical toxicology studies. The
higher dose also will require additional product development and the manufacturing time is
estimated at approximately 18 months. What is the best regulatory approach?
A. Current clinical protocol recruitment should be put on hold for two years to await the new drug
product
B. The current clinical protocol should be terminated and a new clinical protocol written with new
dosing supported by nonclinical studies.
C. The clinical protocol should be ame - answer>>>B.
Trials that are inactive for two years are put on FDA inactive list
Good Manufacturing Practices (GMPs) are NOT applied to the chemical synthesis of an Active
Pharmaceutical Ingredient (API) manufacturing process during:
A. Intermediate compound drying
B. Introduction of the starting material into the process
C. Starting material synthesis
D. API Packaging - answer>>>C.
For synthetic processes, the introduction of the starting material into the manufacturing process is
known as the point at which GMPs are applied in API manufacture. Starting materials synthesis
does not have to be completed under GMPs.
Once an Investigational New Drug (IND) is in effect, an amendment can be submitted for all the
following EXCEPT:
2|Page
,A. The sponsor intends to conduct a clinical investigation with an exception from Informed
Consent for emergency research
B. A change in a Phase 3 protocol significantly affecting subjects' safety, the investigation's scope
or the study's scientific quality
C. Addition of a new investigator to carry out a previously submitted protocol
D. Submission of new toxicology, chemistry or other technical information, or a report regarding
the discontinuation of a clinical investigation - answer>>>A.
Whenever a sponsor intends to conduct a clinical investigation with an exception from Informed
Consent for emergency research as set forth in 21 CFR 50.24, the sponsor shall submit a separate
IND to FDA for such investigation. The other choices should be submitted as IND amendments.
Which of the following statements is TRUE for Phase 2 clinical investigations of a NCE?
A. They are designed to determine the metabolism and pharmacologic actions of the drug in
humans.
B. They are intended to gather additional information about effectiveness and safety to evaluate
the overall benefit-risk of the drug.
C. They are conducted to determine the common short-term side effects and risks associated with
the drug.
D. They are performed to provide an adequate basis for physician labeling. - answer>>>C.
Answer 3 is true for Phase 2 studies, answer 1 is true for Phase 1 studies and answers 2 and 4 are
true for Phase 3 studies.
Sponsors of a clinical trial must immediately notify FDA and investigators of serious adverse
events EXCEPT:
A. Temporally associated with the investigational item's use but are not serious and/or
unexpected
B. Described in the Investigator's Brochure but with greater severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the
drug - answer>>>A.
Events that are not undesirable are not adverse events. Events in animals are not reportable. Events
of greater severity than described in the Investigator's Brochure are unexpected and therefore
reportable.
According to 21 CFR 312.32:
Answer 2, unexpected fatal or life-threatening suspected adverse reactions, should be reported.
The sponsor also must notify FDA of any unexpected fatal or life- threatening suspected adverse
3|Page
, reaction as soon as possible, but in no case later than seven calendar days after the sponsor's initial
receipt of the information.
Additionally, according to the Guidance for Clinical Investigators, Sponsors and IRBs—Adverse Event
Reporting to IRBs—Improving Human Subject Protection:
An AE that is described or addressed in the Investigator's Brochure, protocol or informed consent
documents, but occurs at a specificity or severity inconsistent with prior
observations should be reported.
According to 21 CFR 312.32, answer ID 3, increased rate of occurrence of serious adverse reaction,
should be reported.
The sponsor must report any clinically important increase in the rate of a serious suspected adverse
reaction over than listed in the protocol or Investigator Brochure. According to 21 CFR 312.32,
answer ID 4, iii) findings coming from animal or in vitro testing, also should be reported. The
sponsor must report any findings from animal or in vitro testing, whether or not conducted by the
sponsor, that suggest a significant risk in humans exposed to the drug, such as mutagenicity,
teratogenicity or carcinogenicity reports, or reports of significant organ toxicity at or near the
expected human exposure.
Your company is making a change to a specification to comply with an official compendium of an
NDA product. How should this change be reported?
A. In a CBE-30 due to the moderate potential of the change to have an adverse effect
B. As an update in the next Annual Report
C. In a new letter of authorization
D. There is no need to report this change -
answer>>>B. Minor Changes (Annual Report)
The following are examples of changes in specifications considered to have a minimal potential to
have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as
these factors may relate to the safety or effectiveness of the drug product.
Any change in a specification made to comply with an official compendium, except the changes
described in section VIII.C.1.e, that is consistent with FDA statutory and regulatory requirements
(§ 314.70(d)(2)(i)).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM070621.pdf
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM070621.pdf)
For compendial drug products approved under an NDA or ANDA, changes made to the
specifications in the approved application regarding General Chapter <467> should be in
4|Page
