RAC-DRUGS ONLY ALL PRACTICE EXAM FINAL
(COMPILED) QUESTIONSBANK WITH ACTUAL
SOLUTIONS!!
1 of 596
Term
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) Broadcast communication 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
Give this one a try later!
A. Re-audit the company's corrective actions before the letter is sent
A. The letter from the supervisor states the corrective actions have already taken
place. The firm may be subject to inspection at any time; therefore, these
corrections should be reviewed. Title 18 of the US Code makes submitting false
information to the government a criminal offense.
B. To ensure corrections are in place prior to an official statement by the firm, an
audit should not be delayed until after issuance of the letter to the FDA.
C. See explanation B.
D. See explanation B.
A. Special Protocol Assessment (SPA)
Type A meetings generally will be reserved for dispute resolution meetings,
meetings to discuss clinical holds and Special Protocol Assessment meetings
requested by sponsors after FDA's evaluation of protocols (e.g., animal
carcinogenicity protocols, final product stability protocols and clinical protocols
for Phase 3 trials) in assessment letters.
Type B meetings are
(1) pre-IND meetings (21 CFR 312.82)
(2) certain end of Phase 1 meetings (21 CFR 312.82)
(3) end of Phase 2/pre-Phase 3 meetings (21 CFR 312.47) and
(4) pre-NDA/BLA meetings (21 CFR 312.47).
C) Broadcast communication directing the audience to "see your doctor"
for certain medical conditions or diseases" is not regulated by FDA
A: With limited exception, FDA does not "approve" advertisements and
promotional labeling
There can be situations where the promotional piece must be submitted to
FDA for pre-approval; for example:
accelerated approval drugs, part of an enforcement action, "extraordinary
circumstances"
, B: not true.
D: Promotion is allowed but must be submitted either within 120 days of
marketing approval or 30 days prior to dissemination 21 CFR 314.550
B. Field copy certification
Field copy certification only applies to NDA products, whereas all of the others
sections are requirements for both BLAs and NDAs.
Don't know?
2 of 596
Term
Your company's drug product is a little yellow pill. A pharmacist tells
a sales rep that several customers complained that your little yellow
pill looks a lot like another other little yellow pill. One customer
explained how they took the wrong pill and got very dizzy. The sales
rep informs you about those complaints. How should this be
reported to FDA?
A. As a FIELD Alert report sent within 15 days
B. As a FIELD Alert report sent within three days
C. As an Annual Report
D. As a distribution data report
Give this one a try later!
A. A reserve sample representative of one lot of shipped product per year must
be retained
, A reserve sample representative of each lot of each shipment of each active
ingredient shall be retained—NOT one lot of shipped product per year.
C. The change does not have to be reported because it is an OTC monograph
drug.
As this is an OTC monograph product there would be no FDA administrative file
to report the change to.
A) Request Special Protocol Assessment
A) Special Protocol Assessment is the best choice, this option applies to Phase
3/pivotal studies and the time to request such an assessment would be prior to
commencing the study.
Not D because Subpart H is based on surrogate endpoints, ie, something not
well established
Eliminate C) Priority review since this would be requested when you submit the
marketing application, not prior to Phase 3 studies
B) Fast Track Designation may seem an OK choice; however, you can request FT
designation at any time so this isn't the best choice.
B. As a FIELD Alert report sent within three days
Rapid communication methods are utilized to provide the information the
drug product has been mistaken for another article.
Don't know?
3 of 596
Term
While examining complaint files, a quality assurance professional
notices that there are several complaints of microbial contamination
of one product lot. To determine the possible source of the
problem, what records should be examined first?
(COMPILED) QUESTIONSBANK WITH ACTUAL
SOLUTIONS!!
1 of 596
Term
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) Broadcast communication 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
Give this one a try later!
A. Re-audit the company's corrective actions before the letter is sent
A. The letter from the supervisor states the corrective actions have already taken
place. The firm may be subject to inspection at any time; therefore, these
corrections should be reviewed. Title 18 of the US Code makes submitting false
information to the government a criminal offense.
B. To ensure corrections are in place prior to an official statement by the firm, an
audit should not be delayed until after issuance of the letter to the FDA.
C. See explanation B.
D. See explanation B.
A. Special Protocol Assessment (SPA)
Type A meetings generally will be reserved for dispute resolution meetings,
meetings to discuss clinical holds and Special Protocol Assessment meetings
requested by sponsors after FDA's evaluation of protocols (e.g., animal
carcinogenicity protocols, final product stability protocols and clinical protocols
for Phase 3 trials) in assessment letters.
Type B meetings are
(1) pre-IND meetings (21 CFR 312.82)
(2) certain end of Phase 1 meetings (21 CFR 312.82)
(3) end of Phase 2/pre-Phase 3 meetings (21 CFR 312.47) and
(4) pre-NDA/BLA meetings (21 CFR 312.47).
C) Broadcast communication directing the audience to "see your doctor"
for certain medical conditions or diseases" is not regulated by FDA
A: With limited exception, FDA does not "approve" advertisements and
promotional labeling
There can be situations where the promotional piece must be submitted to
FDA for pre-approval; for example:
accelerated approval drugs, part of an enforcement action, "extraordinary
circumstances"
, B: not true.
D: Promotion is allowed but must be submitted either within 120 days of
marketing approval or 30 days prior to dissemination 21 CFR 314.550
B. Field copy certification
Field copy certification only applies to NDA products, whereas all of the others
sections are requirements for both BLAs and NDAs.
Don't know?
2 of 596
Term
Your company's drug product is a little yellow pill. A pharmacist tells
a sales rep that several customers complained that your little yellow
pill looks a lot like another other little yellow pill. One customer
explained how they took the wrong pill and got very dizzy. The sales
rep informs you about those complaints. How should this be
reported to FDA?
A. As a FIELD Alert report sent within 15 days
B. As a FIELD Alert report sent within three days
C. As an Annual Report
D. As a distribution data report
Give this one a try later!
A. A reserve sample representative of one lot of shipped product per year must
be retained
, A reserve sample representative of each lot of each shipment of each active
ingredient shall be retained—NOT one lot of shipped product per year.
C. The change does not have to be reported because it is an OTC monograph
drug.
As this is an OTC monograph product there would be no FDA administrative file
to report the change to.
A) Request Special Protocol Assessment
A) Special Protocol Assessment is the best choice, this option applies to Phase
3/pivotal studies and the time to request such an assessment would be prior to
commencing the study.
Not D because Subpart H is based on surrogate endpoints, ie, something not
well established
Eliminate C) Priority review since this would be requested when you submit the
marketing application, not prior to Phase 3 studies
B) Fast Track Designation may seem an OK choice; however, you can request FT
designation at any time so this isn't the best choice.
B. As a FIELD Alert report sent within three days
Rapid communication methods are utilized to provide the information the
drug product has been mistaken for another article.
Don't know?
3 of 596
Term
While examining complaint files, a quality assurance professional
notices that there are several complaints of microbial contamination
of one product lot. To determine the possible source of the
problem, what records should be examined first?
