RAC-Drugs Only All Practice Exam Final
According to the Quality System Regulation, when an investigation of a complaint is conducted all of
the following are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant -
☑️ C.
A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should:
A. Write a letter to FDA requesting a Type A meeting as an amendment to the IND
B. Request a Type B meeting as an amendment to the IND
C. Call the project manager and set up a date over the phone for a Type C meeting
D. Email the division director with a list of three dates, 30 days into the future -
☑️ B.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938 passage of
A. The Pure Food and Drug Act
B. The Federal Food Drug and Cosmetic Act
C. The Kefauver-Harris Drug Amendments
D. The Public Health Service Act -
☑️ B. The Federal Food Drug and Cosmetic Act
What products are exempt from the Prescription Drug User Fees Act (PDUFA)?
A. Generic drugs only
B. Orphan drugs and cosmetics only
C. OTC drugs, cosmetics, generic drugs and medical devices
D. Prescription drugs marketed before 1992 -
☑️ C. OTC drugs, cosmetics, generic drugs and medical devices
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM -
☑️ C. CFER
What is the mission of the FDA?
,A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above -
☑️ D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated
records:
True or False -
☑️ FALSE
Veterinary drugs are regulated under the Center for Drug Evaluation and Research (CDER), because
the requirements for approval are the same:
True or False -
☑️ FALSE
In order of highest level to lowest level, the ranking at US governmental organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division -
☑️ B. Department, Agency, Center, Office, Division
For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of
the following intervals?
A. 1 month
B. quarterly
C. at completion
D. periodically -
☑️ D. periodically
Audits should be conducted at intervals appropriate to assure the integrity of the study (rules out
answers A,B and C).
Periodic auditing by the quality assurance unit is required as appropriate for the study
(21CFR58.35(b)(3)
Good Laboratory Practices Regulations govern the:
A. Conduct and control of laboratory activities
B. Conduct of nonclinical laboratory studies
C. Determination of product efficacy in animals
D. Determination of product feasibility -
☑️ B. Conduct of nonclinical laboratory studies
A. The regulation does not cover physical or chemical testing
,B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety
C. Testing to determine utility is excluded
D. Basic exploratory studies are excluded
Consent from subjects for clinical study enrollment is a:
A. Proposed rule
B. Final rule
C. Recommendation
D. Guideline -
☑️ B. Final rule
The FDA regulation on informed consent became a final rule on 27 January 1981 (21 CFR 50)
All of the following are requirements of an IRB, EXCEPT
A. Has at least 5 members
B. Includes at least 1 nonscientific member
C. Obtains informed consent from all subjects
D. Represents the cultural mix of the community -
☑️ C. Obtains informed consent from all subjects
A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a)
B. The regulations require each IRB to have at least 1 member whose primary concerns are in the
scientific area and at least 1 whose primary concerns are in nonscientific areas ((21 CFR56.107(c)
C. It is the responsibility of the clinical investigator to obtain consent from all subjects, not the IRB
(21 CFR 312.60)
D. The regulations require each IRB to have a diversity of members (race, gender, cultural
backgrounds ) (21 CFR56.107(a)
Financial Disclosure is required for investigators who, during the time the clinical investigator is
carrying out the study and for one year following the completion of the study, have:
A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD
B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study began
D. Is not a requirement for Phase 2 studies -
☑️ A. Been a prior employee of the sponsor company and own stock worth more than $50,000
USD
Phase 2 clinical trials are being planned for a novel cancer drug. All the following are appropriate
factors in the phase of the study EXCEPT?
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D. Collection of efficacy data -
, ☑️ C. Study of one or more indications
Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs EXCEPT?
A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
B. Described in the IB 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 -
☑️ A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
From a subsidiary in Ireland, you are forwarded a report that a patient taking your drug was
hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is not listed on
your label. You should report this case to FDA:
A. Within 15 calendar days of receipt
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report -
☑️ A. Within 15 calendar days of receipt
Which of the following subsystems is NOT required by FDA in order to implement and maintain a
Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls -
☑️ B. Test and control article characterization
This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not
by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals
are required by 21CFR 211, Subpart I.
In order to ensure that a facility complies with GMP requirements, all of the following features should
be evaluated EXCEPT:
A. Air handling system
B. Animal supply facilities
C. Lighting
D. Potable water -
☑️ B. Animal supply facilities
Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR
58.45.
According to the Quality System Regulation, when an investigation of a complaint is conducted all of
the following are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant -
☑️ C.
A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should:
A. Write a letter to FDA requesting a Type A meeting as an amendment to the IND
B. Request a Type B meeting as an amendment to the IND
C. Call the project manager and set up a date over the phone for a Type C meeting
D. Email the division director with a list of three dates, 30 days into the future -
☑️ B.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938 passage of
A. The Pure Food and Drug Act
B. The Federal Food Drug and Cosmetic Act
C. The Kefauver-Harris Drug Amendments
D. The Public Health Service Act -
☑️ B. The Federal Food Drug and Cosmetic Act
What products are exempt from the Prescription Drug User Fees Act (PDUFA)?
A. Generic drugs only
B. Orphan drugs and cosmetics only
C. OTC drugs, cosmetics, generic drugs and medical devices
D. Prescription drugs marketed before 1992 -
☑️ C. OTC drugs, cosmetics, generic drugs and medical devices
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM -
☑️ C. CFER
What is the mission of the FDA?
,A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above -
☑️ D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated
records:
True or False -
☑️ FALSE
Veterinary drugs are regulated under the Center for Drug Evaluation and Research (CDER), because
the requirements for approval are the same:
True or False -
☑️ FALSE
In order of highest level to lowest level, the ranking at US governmental organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division -
☑️ B. Department, Agency, Center, Office, Division
For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of
the following intervals?
A. 1 month
B. quarterly
C. at completion
D. periodically -
☑️ D. periodically
Audits should be conducted at intervals appropriate to assure the integrity of the study (rules out
answers A,B and C).
Periodic auditing by the quality assurance unit is required as appropriate for the study
(21CFR58.35(b)(3)
Good Laboratory Practices Regulations govern the:
A. Conduct and control of laboratory activities
B. Conduct of nonclinical laboratory studies
C. Determination of product efficacy in animals
D. Determination of product feasibility -
☑️ B. Conduct of nonclinical laboratory studies
A. The regulation does not cover physical or chemical testing
,B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety
C. Testing to determine utility is excluded
D. Basic exploratory studies are excluded
Consent from subjects for clinical study enrollment is a:
A. Proposed rule
B. Final rule
C. Recommendation
D. Guideline -
☑️ B. Final rule
The FDA regulation on informed consent became a final rule on 27 January 1981 (21 CFR 50)
All of the following are requirements of an IRB, EXCEPT
A. Has at least 5 members
B. Includes at least 1 nonscientific member
C. Obtains informed consent from all subjects
D. Represents the cultural mix of the community -
☑️ C. Obtains informed consent from all subjects
A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a)
B. The regulations require each IRB to have at least 1 member whose primary concerns are in the
scientific area and at least 1 whose primary concerns are in nonscientific areas ((21 CFR56.107(c)
C. It is the responsibility of the clinical investigator to obtain consent from all subjects, not the IRB
(21 CFR 312.60)
D. The regulations require each IRB to have a diversity of members (race, gender, cultural
backgrounds ) (21 CFR56.107(a)
Financial Disclosure is required for investigators who, during the time the clinical investigator is
carrying out the study and for one year following the completion of the study, have:
A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD
B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study began
D. Is not a requirement for Phase 2 studies -
☑️ A. Been a prior employee of the sponsor company and own stock worth more than $50,000
USD
Phase 2 clinical trials are being planned for a novel cancer drug. All the following are appropriate
factors in the phase of the study EXCEPT?
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D. Collection of efficacy data -
, ☑️ C. Study of one or more indications
Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs EXCEPT?
A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
B. Described in the IB 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 -
☑️ A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
From a subsidiary in Ireland, you are forwarded a report that a patient taking your drug was
hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is not listed on
your label. You should report this case to FDA:
A. Within 15 calendar days of receipt
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report -
☑️ A. Within 15 calendar days of receipt
Which of the following subsystems is NOT required by FDA in order to implement and maintain a
Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls -
☑️ B. Test and control article characterization
This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not
by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals
are required by 21CFR 211, Subpart I.
In order to ensure that a facility complies with GMP requirements, all of the following features should
be evaluated EXCEPT:
A. Air handling system
B. Animal supply facilities
C. Lighting
D. Potable water -
☑️ B. Animal supply facilities
Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR
58.45.
