RAC Practice Exam 2025\|| Most Recent Exam Actual
Complete Real Exam 100 Questions And Correct
Answers (Verified Answers) Already Graded A+ |
Guaranteed Success!! Newest Exam | Just Released
2026-2027
The regulatory affairs professional performs all of the following prior to
submitting a PMA to FDA EXCEPT:
A. Preparing criteria for the MDR report.
B. Preparing a brief statement of reasons for noncompliance with regulation.
C. Identifying all omissions in PMA content.
D. Reviewing, organizing and checking adequacy of data pertaining to safety
and efficacy evaluation.
A. Preparing criteria for the MDR report.
MDR reporting is a post PMA approval requirement.
,Which of the following documentation is NOT included in a Biologics License
Application?
A. Stability data.
B. Product labeling.
C. GLP compliance statement(s).
D. Overall quality summary.
D. Overall quality summary.
An overall quality summary is a CTD requirement, not a BLA requirement.
Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB.
B. Protecting the rights, safety and welfare of study subjects.
C. Controlling the drug under investigation.
D. Returning unused supplies of the drug to the sponsor.
A. Providing a final study report to the IRB.
21 CFR 312.64 - The investigator is not obligated to submit reports to the IRB.
Investigators are responsible for submitting reports to the sponsor (i.e. -
progress reports, safety reports, a final report).
,To be legally effective, a witness must observe the informed consent process
at which of the following times?
A. When the study subject is a minor.
B. When the elements of informed consent are presented orally.
C. When the consent is obtained from the subject's legal representative.
D. When the elements of informed consent are written in a foreign language.
B. When the elements of informed consent are presented orally.
FDA regulations require a witness to an oral presentation of elements of informed
consent to the subject or the subject's legally authorized representation. 21 CFR
50.27(b) (2).
FDA will do a for-cause inspection of an investigator if the investigator:
A. Conducts a number of pivotal NDA studies.
B. Is only participating in a small number of studies.
C. Appears to have an excessive number of study projects.
D. Consistently reports results different from other investigators.
D. Consistently reports results different from other investigators.
An inspection will be conducted if an investigator's results are inconsistent with
those of other investigators and fraud is suspected.
, Which of the following federal laws includes information about ANDA
submissions?
A. Antibiotic Amendments of 1945.
B. Durham-Humphrey Amendment of 1951.
C. Drug Amendments of 1962.
D. Drug Price Competition and Patent Term Restoration Act of 1984.
D. Drug Price Competition and Patent Term Restoration Act of 1984.
This Act permitted manufacturers to use abbreviated NDAs to gain approval
for generic versions of approved drugs whose patents had expired.
Complete Real Exam 100 Questions And Correct
Answers (Verified Answers) Already Graded A+ |
Guaranteed Success!! Newest Exam | Just Released
2026-2027
The regulatory affairs professional performs all of the following prior to
submitting a PMA to FDA EXCEPT:
A. Preparing criteria for the MDR report.
B. Preparing a brief statement of reasons for noncompliance with regulation.
C. Identifying all omissions in PMA content.
D. Reviewing, organizing and checking adequacy of data pertaining to safety
and efficacy evaluation.
A. Preparing criteria for the MDR report.
MDR reporting is a post PMA approval requirement.
,Which of the following documentation is NOT included in a Biologics License
Application?
A. Stability data.
B. Product labeling.
C. GLP compliance statement(s).
D. Overall quality summary.
D. Overall quality summary.
An overall quality summary is a CTD requirement, not a BLA requirement.
Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB.
B. Protecting the rights, safety and welfare of study subjects.
C. Controlling the drug under investigation.
D. Returning unused supplies of the drug to the sponsor.
A. Providing a final study report to the IRB.
21 CFR 312.64 - The investigator is not obligated to submit reports to the IRB.
Investigators are responsible for submitting reports to the sponsor (i.e. -
progress reports, safety reports, a final report).
,To be legally effective, a witness must observe the informed consent process
at which of the following times?
A. When the study subject is a minor.
B. When the elements of informed consent are presented orally.
C. When the consent is obtained from the subject's legal representative.
D. When the elements of informed consent are written in a foreign language.
B. When the elements of informed consent are presented orally.
FDA regulations require a witness to an oral presentation of elements of informed
consent to the subject or the subject's legally authorized representation. 21 CFR
50.27(b) (2).
FDA will do a for-cause inspection of an investigator if the investigator:
A. Conducts a number of pivotal NDA studies.
B. Is only participating in a small number of studies.
C. Appears to have an excessive number of study projects.
D. Consistently reports results different from other investigators.
D. Consistently reports results different from other investigators.
An inspection will be conducted if an investigator's results are inconsistent with
those of other investigators and fraud is suspected.
, Which of the following federal laws includes information about ANDA
submissions?
A. Antibiotic Amendments of 1945.
B. Durham-Humphrey Amendment of 1951.
C. Drug Amendments of 1962.
D. Drug Price Competition and Patent Term Restoration Act of 1984.
D. Drug Price Competition and Patent Term Restoration Act of 1984.
This Act permitted manufacturers to use abbreviated NDAs to gain approval
for generic versions of approved drugs whose patents had expired.
