RAC EXAM 2025 Test Bank Final Exam Questions &
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What is FDA's review timeframe for a MDUFA?
Decision is within 30 days after receiving the recommendation of a third-
party organization
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) was developed for what reason?
To harmonize product registration requirements using technical guidelines to
reduce or avoid duplicate testing during new drug research and development
MedDRA
Is designed to support medical information classification, retrieval, presentation,
and communication throughout the drug and medical
device regulatory cycle.
Important in electronic adverse event report coding and transmissions and
clinical trial data coding.
Some examples of what led to the creation of GCPs?
1937 Sulfanilamide disaster
Tuskegee Syphilis Study
,Medical Device Amendments 1976
Established medical device classification system
Established premarket requirements for Class III
devices. Established the 510(k) process
Established safety and efficacy requirements
Established Investigation Device Exemptions (IDEs)
National Research Act
Authorized federal agencies to develop human research regulations for
government- funded research involving human subjects.
Required the development of Institutional Review Boards (IRBs) for the
protection of human research subjects
Belmont Report 1979
Report released by the National Commission establishing ethical principles for
research in
human subjects
,Food and Drug Administration Amendments Act 2007
Required all clinical trials (except Phase 1) to be registered in the clinical trial
registry databank
(ClinicalTrials.gov)
Required results from clinical trials that serve as the basis for efficacy claims and
postmarketing studies to be posted on ClinicalTrials.gov
Reauthorized PDUFA
Reauthorized and expanded MDUFMA
The Tuskegee Study of Untreated Syphilis in the Negro Male
The study initially involved 600 Black men - 399 with syphilis, 201 who did not
have the disease. Participants' informed consent was not collected.
Copper Committee
Called for risk-based medical device assessment based on potential
hazards and specific mechanisms, as well as requirements for reporting and
recordkeeping, good manufacturing practices (GMPs), and agency
inspections.
Dalkon Shield Intrauterine Device (IUD) incident
209 US cases of septic spontaneous abortion and 11 maternal deaths were
reported from the time the device entered the market in 1970 until its removal
in 1976
, How does an informed consent work?
involves providing a potential subject with sufficient information to allow an
informed decision about participating in the clinical investigation, facilitating the
potential subject's understanding of the information, providing
adequate opportunity for a potential subject to ask questions and consider
whether to participate, obtaining the potential subject's voluntary agreement
to participate, and continuing to provide information as the clinical
investigation progresses or as the subject or situation requires
What is an Institutional Review Board (IRB)?
An appropriately constituted group formally designated to review and
monitor biomedical research involving human subjects to ensure subjects'
rights and welfare are protected
IRB must include
One member whose primary concern is in the scientific area, and at least one
whose primary concern is in a nonscientific area.
One member who is not otherwise affiliated with the institution and whose
immediate family does not include a person affiliated with the institution.
Three IRB review situations
Exempt from IRB review
Expedited review
Full board (convened) IRB review
Answers || Most Recent Exam Actual Complete Real
Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ | Guaranteed Success!!
Newest Exam | Just Released 2026-2027
What is FDA's review timeframe for a MDUFA?
Decision is within 30 days after receiving the recommendation of a third-
party organization
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) was developed for what reason?
To harmonize product registration requirements using technical guidelines to
reduce or avoid duplicate testing during new drug research and development
MedDRA
Is designed to support medical information classification, retrieval, presentation,
and communication throughout the drug and medical
device regulatory cycle.
Important in electronic adverse event report coding and transmissions and
clinical trial data coding.
Some examples of what led to the creation of GCPs?
1937 Sulfanilamide disaster
Tuskegee Syphilis Study
,Medical Device Amendments 1976
Established medical device classification system
Established premarket requirements for Class III
devices. Established the 510(k) process
Established safety and efficacy requirements
Established Investigation Device Exemptions (IDEs)
National Research Act
Authorized federal agencies to develop human research regulations for
government- funded research involving human subjects.
Required the development of Institutional Review Boards (IRBs) for the
protection of human research subjects
Belmont Report 1979
Report released by the National Commission establishing ethical principles for
research in
human subjects
,Food and Drug Administration Amendments Act 2007
Required all clinical trials (except Phase 1) to be registered in the clinical trial
registry databank
(ClinicalTrials.gov)
Required results from clinical trials that serve as the basis for efficacy claims and
postmarketing studies to be posted on ClinicalTrials.gov
Reauthorized PDUFA
Reauthorized and expanded MDUFMA
The Tuskegee Study of Untreated Syphilis in the Negro Male
The study initially involved 600 Black men - 399 with syphilis, 201 who did not
have the disease. Participants' informed consent was not collected.
Copper Committee
Called for risk-based medical device assessment based on potential
hazards and specific mechanisms, as well as requirements for reporting and
recordkeeping, good manufacturing practices (GMPs), and agency
inspections.
Dalkon Shield Intrauterine Device (IUD) incident
209 US cases of septic spontaneous abortion and 11 maternal deaths were
reported from the time the device entered the market in 1970 until its removal
in 1976
, How does an informed consent work?
involves providing a potential subject with sufficient information to allow an
informed decision about participating in the clinical investigation, facilitating the
potential subject's understanding of the information, providing
adequate opportunity for a potential subject to ask questions and consider
whether to participate, obtaining the potential subject's voluntary agreement
to participate, and continuing to provide information as the clinical
investigation progresses or as the subject or situation requires
What is an Institutional Review Board (IRB)?
An appropriately constituted group formally designated to review and
monitor biomedical research involving human subjects to ensure subjects'
rights and welfare are protected
IRB must include
One member whose primary concern is in the scientific area, and at least one
whose primary concern is in a nonscientific area.
One member who is not otherwise affiliated with the institution and whose
immediate family does not include a person affiliated with the institution.
Three IRB review situations
Exempt from IRB review
Expedited review
Full board (convened) IRB review
