RAC-Drugs Only All Practice
Exam. ANWERS AND
QUESTIONS WHICH AR HIGHLY
VERIFIED
24. A firm received a raw material for one of its drug products. The raw material was placed into
quarantine and samples appropriately. Sample containers should be identified so that the
following information can be determined:
A. The manufacturer name lot number name of person who collected the sample, and the date on
which the sample was taken
B. The manufacturer, the lot number, the sample attributes, name of person that collected the
sample, and the date on which the sample was taken
C. The material name, lot number, the container from which the sample was taken, name of
person who collected the sample, and the date on which the sample was taken
D. The material name, lot number, sample attributes, and the date on which the sample was taken
C. The material name, lot number, the container from which the sample was taken, name
of person who collected the sample, and the date on which the sample was taken
25. Once an investigation New Drug (IND) is in effect, an amendment can be submitted for all
the following EXCEPT:
A. The sponsor intends to conduct a clinical investigation with an exception from informed
consent for emergency research
B. A change in a Phase 3 protocol that significantly affects the safety of the subject, the scope of
the investigation or the scientific quality of the study
C. When a new investigator is added to carry out a previously submitted protocol
D. Submission of new toxicology, chemistry or other technical information, or a report regarding
the discontinuation of a clinical investigation B. A change in a Phase 3 protocol that
significantly affects the safety of the subject, the scope of the investigation or the scientific
quality of the study
26. Your company recently submitted a Biologics License Application (BLA) to CDER and the
review division has notified you that you must develop and submit a Medication Guide. This
request may have resulted from any of the following EXCEPT:
A. The product is once for which patient labeling could help prevent serous adverse effects
B. The product is one that has been demonstrated though adequate and well-controlled trials to
be less effective than alternative therapies
C. The product is one that has serious risks relative to benefits that must be communicated to the
patients
,D. The product is important to health and patient adherence to directions for use is crucial to the
drug's effectiveness B. The product is one that has been demonstrated though adequate and
well-controlled trials to be less effective than alternative therapies
5 -year exclusivity is given to which of the following applications:
A. Orphan drug
B. Pediatric
C. New Chemical Entity (NCE)
D. Patent Challenge (PC) C. New Chemical Entity (NCE)
A 505(b)(2) NDA is NOT an appropriate regulatory submission for the approval to market a:
A. New Chemical Entity when FDA relies for approval on data not developed by the applicant
B. Different route of administration for an approved product
C. Combination of two active ingredients that have been approved individually
D. New Chemical Entity when the sponsor has a right of reference to all applicable published
studies D. New Chemical Entity when the sponsor has a right of reference to all applicable
published studies
A 505(b)2 NDA is an application where approval of the new drug relies on data at least in part
that is not developed by the applicant.
505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a
drug for which the investigations described in section 505(b)(1)(A) of the act
and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person
by or for whom the investigations were conducted.
A blood center has discovered a unit of packed red blood cells previously shipped to a local
hospital was stored inappropriately for four days during the manufacturing process. The blood
center should:
A. Recall the blood product and initiate a blood product deviation report to CBER within 45
calendar days of discovery of the deviation.
B. Recall the blood product and initiate a blood product deviation report to CDRH within 45
calendar days of discovery of the deviation.
C. Recall the blood product and initiate a blood product deviation report to CBER within 15
calendar days of discovery of the deviation.
D. Recall the blood product and initiate a blood product deviation report to CDRH within 15
calendar days of discovery of the deviation. A. Recall the blood product and initiate a blood
product deviation report to CBER within 45 calendar days of discovery of the deviation.
The appropriate FDA branch handling biologic products is CBER and the appropriate reporting
period is 45 days from discovery of the manufacturing deviation.
Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the
manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or
distribution of blood or a blood component, which may affect the safety, purity or potency of a
distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s).
,Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is
required to submit reports at a date not to exceed 45 calendar days from the date of discovery of
information reasonably suggesting a reportable event has occurred.
A blood center has discovered a unit of packed red blood cells previously shipped to a local
hospital was stored inappropriately for four days during the manufacturing process. The blood
center should:
A. Recall the blood product and initiate a blood product deviation report to CBER within 45
calendar days of discovery of the deviation.
B. Recall the blood product and initiate a blood product deviation report to CDRH within 45
calendar days of discovery of the deviation.
C. Recall the blood product and initiate a blood product deviation report to CBER within 15
calendar days of discovery of the deviation.
D. Recall the blood product and initiate a blood product deviation report to CDRH within 15
calendar days of discovery of the deviation. A. Recall the blood product and initiate a blood
product deviation report to CBER within 45 calendar days of discovery of the deviation.
The appropriate FDA branch handling biologic products is CBER and the appropriate reporting
period is 45 days from discovery of the manufacturing deviation.
Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the
manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or
distribution of blood or a blood component, which may affect the safety, purity or potency of a
distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s).
Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is
required to submit reports at a date not to exceed 45 calendar days from the date of discovery of
information reasonably suggesting a reportable event has occurred.
A clinical investigator will conduct Phase 1 pharmacokinetic studies of your company's drug
product. This same investigator also receives a $30,000 retainer to
be on the speaker's bureau for another of your company's products. What information related to
this investigator must be included with your IND submission?
A. Form 3454, certifying lack of financial interests and arrangements.
B. Form 3455, disclosing significant payments from the IND sponsor.
C. Form 3455, disclosing proprietary interest in the tested product.
D. No additional forms are required. D. No additional forms are required.
Phase 1 pharmacokinetic studies are not covered studies, and therefore do not need financial
certification or disclosure.
A clinical study sponsor's representative conducts
periodic monitoring site visits for all of the following purposes EXCEPT to:
A. review raw data
B. ensure compliance with the protocol
C. review the protocol with the investigator
, D. ensure the adequacy of the IRB and its procedures D. ensure the adequacy of the IRB
and its procedures
A. These data are included in source documents, which are reviewed by the study monitor. 21
CFR 812.3(j), 21 CFR 812.25(e), 21 CFR 812.43(d).
B. This is integral to the monitoring function. 21 CFR 812.46, 21 CFR 312.56, 21 CFR 312.66.
C. This step is performed at the study initiation visit and reinforced when necessary. 21 CFR
812.45, 812.46,
21 CFR 312.55.
D. An institution conducting clinical investigations is responsible for the integrity of the IRB and
is held accountable. There is a degree of confidentiality that may not be breached by a study
monitor. The investigator, through the signed 1572 form, assures the sponsor of IRB review. 21
CFR 812.100, 812.110; 21 CFR 312.66, 21 CFR 812.150(a)(2), 812.140(a)(1).
A clinical study sponsor's representative conducts periodic monitoring site visits for all of the
following purposes EXCEPT to:
A. review raw data.
B. audit the adequacy of the study facility.
C. review the protocol with the investigator.
D. ensure the adequacy of the IRB and its
procedures. D. ensure the adequacy of the IRB and its procedures.
A. These data are included in source documents and are integral in the monitoring process.
B. This is essential to assessing a clinical investigation and should be done before the study
begins and evaluated throughout the study.
C. This step is performed at the study initiation visit and reinforced when necessary.
D. An institution conducting clinical investigations is responsible for the integrity of the IRB and
is held accountable. There is a degree of confidentiality which may not be breached by a study
monitor. The investigator, through the signed 1572 Form, assures the sponsor of IRB review.
A clinical trial for a new treatment is recruiting study subjects and wants to use a posting on the
company Facebook page to solicit participants. Does this information need IRB review?
A. No Facebook and other social media programs are not within the jurisdiction of an IRB
B. No not unless it appears after the study has started.
C. Yes Advertising that is intended to be seen or heard by prospective subjects to solicit their
participation in a study requires IRB approval
D. Yes but only if the study is required to appear on the NCI cancer clinical trial listing (PDQ) or
the government sponsored AIDS Clinical trial information services (ACTIS) C. Yes
Advertising that is intended to be seen or heard by prospective subjects to solicit their
participation in a study requires IRB approval
A company acquired a new packaging facility located in the US to package its pharmaceutical
drug products. What must be done for the start up of packaging operations at this facility?
A. Register the establishment with FDA within five days after beginning the operation
B. Contact Dun & Bradstreet to obtain a DUNs number
C. Submit supplement to FDA
Exam. ANWERS AND
QUESTIONS WHICH AR HIGHLY
VERIFIED
24. A firm received a raw material for one of its drug products. The raw material was placed into
quarantine and samples appropriately. Sample containers should be identified so that the
following information can be determined:
A. The manufacturer name lot number name of person who collected the sample, and the date on
which the sample was taken
B. The manufacturer, the lot number, the sample attributes, name of person that collected the
sample, and the date on which the sample was taken
C. The material name, lot number, the container from which the sample was taken, name of
person who collected the sample, and the date on which the sample was taken
D. The material name, lot number, sample attributes, and the date on which the sample was taken
C. The material name, lot number, the container from which the sample was taken, name
of person who collected the sample, and the date on which the sample was taken
25. Once an investigation New Drug (IND) is in effect, an amendment can be submitted for all
the following EXCEPT:
A. The sponsor intends to conduct a clinical investigation with an exception from informed
consent for emergency research
B. A change in a Phase 3 protocol that significantly affects the safety of the subject, the scope of
the investigation or the scientific quality of the study
C. When a new investigator is added to carry out a previously submitted protocol
D. Submission of new toxicology, chemistry or other technical information, or a report regarding
the discontinuation of a clinical investigation B. A change in a Phase 3 protocol that
significantly affects the safety of the subject, the scope of the investigation or the scientific
quality of the study
26. Your company recently submitted a Biologics License Application (BLA) to CDER and the
review division has notified you that you must develop and submit a Medication Guide. This
request may have resulted from any of the following EXCEPT:
A. The product is once for which patient labeling could help prevent serous adverse effects
B. The product is one that has been demonstrated though adequate and well-controlled trials to
be less effective than alternative therapies
C. The product is one that has serious risks relative to benefits that must be communicated to the
patients
,D. The product is important to health and patient adherence to directions for use is crucial to the
drug's effectiveness B. The product is one that has been demonstrated though adequate and
well-controlled trials to be less effective than alternative therapies
5 -year exclusivity is given to which of the following applications:
A. Orphan drug
B. Pediatric
C. New Chemical Entity (NCE)
D. Patent Challenge (PC) C. New Chemical Entity (NCE)
A 505(b)(2) NDA is NOT an appropriate regulatory submission for the approval to market a:
A. New Chemical Entity when FDA relies for approval on data not developed by the applicant
B. Different route of administration for an approved product
C. Combination of two active ingredients that have been approved individually
D. New Chemical Entity when the sponsor has a right of reference to all applicable published
studies D. New Chemical Entity when the sponsor has a right of reference to all applicable
published studies
A 505(b)2 NDA is an application where approval of the new drug relies on data at least in part
that is not developed by the applicant.
505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a
drug for which the investigations described in section 505(b)(1)(A) of the act
and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person
by or for whom the investigations were conducted.
A blood center has discovered a unit of packed red blood cells previously shipped to a local
hospital was stored inappropriately for four days during the manufacturing process. The blood
center should:
A. Recall the blood product and initiate a blood product deviation report to CBER within 45
calendar days of discovery of the deviation.
B. Recall the blood product and initiate a blood product deviation report to CDRH within 45
calendar days of discovery of the deviation.
C. Recall the blood product and initiate a blood product deviation report to CBER within 15
calendar days of discovery of the deviation.
D. Recall the blood product and initiate a blood product deviation report to CDRH within 15
calendar days of discovery of the deviation. A. Recall the blood product and initiate a blood
product deviation report to CBER within 45 calendar days of discovery of the deviation.
The appropriate FDA branch handling biologic products is CBER and the appropriate reporting
period is 45 days from discovery of the manufacturing deviation.
Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the
manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or
distribution of blood or a blood component, which may affect the safety, purity or potency of a
distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s).
,Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is
required to submit reports at a date not to exceed 45 calendar days from the date of discovery of
information reasonably suggesting a reportable event has occurred.
A blood center has discovered a unit of packed red blood cells previously shipped to a local
hospital was stored inappropriately for four days during the manufacturing process. The blood
center should:
A. Recall the blood product and initiate a blood product deviation report to CBER within 45
calendar days of discovery of the deviation.
B. Recall the blood product and initiate a blood product deviation report to CDRH within 45
calendar days of discovery of the deviation.
C. Recall the blood product and initiate a blood product deviation report to CBER within 15
calendar days of discovery of the deviation.
D. Recall the blood product and initiate a blood product deviation report to CDRH within 15
calendar days of discovery of the deviation. A. Recall the blood product and initiate a blood
product deviation report to CBER within 45 calendar days of discovery of the deviation.
The appropriate FDA branch handling biologic products is CBER and the appropriate reporting
period is 45 days from discovery of the manufacturing deviation.
Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the
manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or
distribution of blood or a blood component, which may affect the safety, purity or potency of a
distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s).
Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is
required to submit reports at a date not to exceed 45 calendar days from the date of discovery of
information reasonably suggesting a reportable event has occurred.
A clinical investigator will conduct Phase 1 pharmacokinetic studies of your company's drug
product. This same investigator also receives a $30,000 retainer to
be on the speaker's bureau for another of your company's products. What information related to
this investigator must be included with your IND submission?
A. Form 3454, certifying lack of financial interests and arrangements.
B. Form 3455, disclosing significant payments from the IND sponsor.
C. Form 3455, disclosing proprietary interest in the tested product.
D. No additional forms are required. D. No additional forms are required.
Phase 1 pharmacokinetic studies are not covered studies, and therefore do not need financial
certification or disclosure.
A clinical study sponsor's representative conducts
periodic monitoring site visits for all of the following purposes EXCEPT to:
A. review raw data
B. ensure compliance with the protocol
C. review the protocol with the investigator
, D. ensure the adequacy of the IRB and its procedures D. ensure the adequacy of the IRB
and its procedures
A. These data are included in source documents, which are reviewed by the study monitor. 21
CFR 812.3(j), 21 CFR 812.25(e), 21 CFR 812.43(d).
B. This is integral to the monitoring function. 21 CFR 812.46, 21 CFR 312.56, 21 CFR 312.66.
C. This step is performed at the study initiation visit and reinforced when necessary. 21 CFR
812.45, 812.46,
21 CFR 312.55.
D. An institution conducting clinical investigations is responsible for the integrity of the IRB and
is held accountable. There is a degree of confidentiality that may not be breached by a study
monitor. The investigator, through the signed 1572 form, assures the sponsor of IRB review. 21
CFR 812.100, 812.110; 21 CFR 312.66, 21 CFR 812.150(a)(2), 812.140(a)(1).
A clinical study sponsor's representative conducts periodic monitoring site visits for all of the
following purposes EXCEPT to:
A. review raw data.
B. audit the adequacy of the study facility.
C. review the protocol with the investigator.
D. ensure the adequacy of the IRB and its
procedures. D. ensure the adequacy of the IRB and its procedures.
A. These data are included in source documents and are integral in the monitoring process.
B. This is essential to assessing a clinical investigation and should be done before the study
begins and evaluated throughout the study.
C. This step is performed at the study initiation visit and reinforced when necessary.
D. An institution conducting clinical investigations is responsible for the integrity of the IRB and
is held accountable. There is a degree of confidentiality which may not be breached by a study
monitor. The investigator, through the signed 1572 Form, assures the sponsor of IRB review.
A clinical trial for a new treatment is recruiting study subjects and wants to use a posting on the
company Facebook page to solicit participants. Does this information need IRB review?
A. No Facebook and other social media programs are not within the jurisdiction of an IRB
B. No not unless it appears after the study has started.
C. Yes Advertising that is intended to be seen or heard by prospective subjects to solicit their
participation in a study requires IRB approval
D. Yes but only if the study is required to appear on the NCI cancer clinical trial listing (PDQ) or
the government sponsored AIDS Clinical trial information services (ACTIS) C. Yes
Advertising that is intended to be seen or heard by prospective subjects to solicit their
participation in a study requires IRB approval
A company acquired a new packaging facility located in the US to package its pharmaceutical
drug products. What must be done for the start up of packaging operations at this facility?
A. Register the establishment with FDA within five days after beginning the operation
B. Contact Dun & Bradstreet to obtain a DUNs number
C. Submit supplement to FDA
