RAPS RAC-US Comprehensive Regulatory Affairs
Practice EXAM LATEST 90 QUESTIONS AND 100%
Verified ANSWERS JUST RELEASED
1 Which of the following is typically included in a reminder advertisement?
A) Brand and generic names
B) Indication(s)
C) Dose information
D) Statement of efficacy - answer>>A) Brand and generic names
2 Which of the following is a true statement regarding advertising/promotion of prescription drug
products?
A) All promotional materials must be approved by FDA prior to use
B) All promotional materials must be approved by the Federal Trade Commission
C) Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is
not regulated by FDA
D) Advertising is not allowed for drugs approved under accelerated approval/Subpart H - answer>>C)
Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is
not regulated by FDA
3 Which of the following convey "intended use" for a drug product?
A) Prescribing information
B) Verbal statements by sponsor or sponsor's representative about a product's use at a trade show
C) Printed promotional materials
D) All of the above - answer>>D) All of the above
4 You, a regulatory affairs professional, receive a warning letter from DDMAC pertaining to DTC
advertising. The first thing you do is:
,A) Develop a corrective advertisement
B) Write a response letter to DDMAC
C) Cease dissemination of violative materials
D) Review the marketing application - answer>>C) Cease dissemination of violative materials
4) A label is defined as that which is affixed to the:
A) Carton
B) Shrink Wrapper
C) Shipping Package
D) Immediate Container - answer>>D) Immediate Container
5) You, a regulatory affairs professional, are in a situation where an administrative or procedural
dispute has occurred between the sponsor and the FDA reviewing division. In attempt to resolve the
dispute, on what level would you initially try to resolve the dispute?
A) Review Division
B) Agency Ombudsman
C) Office Director
D) FDA Office of Regulatory Affairs - answer>>A) Review Division
6) The FDA wants to develop a new guidance document on electronic submissions. Initially, the best
way for FDA to obtain industry input for the preparation of a first draft is to
A) Schedule an advisory panel meeting
B) Announce a public hearing on the issue
C) Conduct talks with a number of trade associations
D) Issue a Federal Register notice of intent to promulgate a guidance document - answer>>C) Conduct
talks with a number of trade associations
, 7) Which of the following best describes Advisory Committee meetings?
A) Advisory Committee meetings are always open to the public
B) Advisory Committee meetings only occur in the product approval stage
C) FDA must follow resulting recommendations of Advisory Committee
D) Advisory Committee meetings are a way for FDA to consult with outside experts - answer>>D)
Advisory Committee meetings are a way for FDA to consult with outside experts
8) ADEs that do not meet 15-day reporting requirements should be reported by the applicant:
A) Annually, unless alternate reporting arrangement is required by FDA
B) Semi-annually, unless alternate reporting arrangement is required by FDA
C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting
arrangement is required by FDA
D) Quarterly for 1st year after application is approved, annually thereafter, unless alternate reporting
arrangement is required by FDA - answer>>C) Quarterly for 3 years after application is approved,
annually thereafter, unless alternate reporting arrangement is required by FDA
9) As a regulatory affairs professional, you are provided evidence that your firm's product has been the
subject of criminal tampering post-distribution which has resulted in 2 known deaths. You assemble
the appropriate internal team in order to implement a
A) Class I Recall
B) Class II Recall
C) Class III Recall
D) Market Withdrawal - answer>>D) Market Withdrawal
10) Which of the following examples best represents "fair balance"?
A) Risks and benefits are presented in comparable prominence, readability
B) A reminder ad
C) Established name appears next to brand name in type at least 50% of brand name
Practice EXAM LATEST 90 QUESTIONS AND 100%
Verified ANSWERS JUST RELEASED
1 Which of the following is typically included in a reminder advertisement?
A) Brand and generic names
B) Indication(s)
C) Dose information
D) Statement of efficacy - answer>>A) Brand and generic names
2 Which of the following is a true statement regarding advertising/promotion of prescription drug
products?
A) All promotional materials must be approved by FDA prior to use
B) All promotional materials must be approved by the Federal Trade Commission
C) Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is
not regulated by FDA
D) Advertising is not allowed for drugs approved under accelerated approval/Subpart H - answer>>C)
Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is
not regulated by FDA
3 Which of the following convey "intended use" for a drug product?
A) Prescribing information
B) Verbal statements by sponsor or sponsor's representative about a product's use at a trade show
C) Printed promotional materials
D) All of the above - answer>>D) All of the above
4 You, a regulatory affairs professional, receive a warning letter from DDMAC pertaining to DTC
advertising. The first thing you do is:
,A) Develop a corrective advertisement
B) Write a response letter to DDMAC
C) Cease dissemination of violative materials
D) Review the marketing application - answer>>C) Cease dissemination of violative materials
4) A label is defined as that which is affixed to the:
A) Carton
B) Shrink Wrapper
C) Shipping Package
D) Immediate Container - answer>>D) Immediate Container
5) You, a regulatory affairs professional, are in a situation where an administrative or procedural
dispute has occurred between the sponsor and the FDA reviewing division. In attempt to resolve the
dispute, on what level would you initially try to resolve the dispute?
A) Review Division
B) Agency Ombudsman
C) Office Director
D) FDA Office of Regulatory Affairs - answer>>A) Review Division
6) The FDA wants to develop a new guidance document on electronic submissions. Initially, the best
way for FDA to obtain industry input for the preparation of a first draft is to
A) Schedule an advisory panel meeting
B) Announce a public hearing on the issue
C) Conduct talks with a number of trade associations
D) Issue a Federal Register notice of intent to promulgate a guidance document - answer>>C) Conduct
talks with a number of trade associations
, 7) Which of the following best describes Advisory Committee meetings?
A) Advisory Committee meetings are always open to the public
B) Advisory Committee meetings only occur in the product approval stage
C) FDA must follow resulting recommendations of Advisory Committee
D) Advisory Committee meetings are a way for FDA to consult with outside experts - answer>>D)
Advisory Committee meetings are a way for FDA to consult with outside experts
8) ADEs that do not meet 15-day reporting requirements should be reported by the applicant:
A) Annually, unless alternate reporting arrangement is required by FDA
B) Semi-annually, unless alternate reporting arrangement is required by FDA
C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting
arrangement is required by FDA
D) Quarterly for 1st year after application is approved, annually thereafter, unless alternate reporting
arrangement is required by FDA - answer>>C) Quarterly for 3 years after application is approved,
annually thereafter, unless alternate reporting arrangement is required by FDA
9) As a regulatory affairs professional, you are provided evidence that your firm's product has been the
subject of criminal tampering post-distribution which has resulted in 2 known deaths. You assemble
the appropriate internal team in order to implement a
A) Class I Recall
B) Class II Recall
C) Class III Recall
D) Market Withdrawal - answer>>D) Market Withdrawal
10) Which of the following examples best represents "fair balance"?
A) Risks and benefits are presented in comparable prominence, readability
B) A reminder ad
C) Established name appears next to brand name in type at least 50% of brand name
