RAC Practice Exam 1 Update Questions
with Verified Answers Download to
Score 100%
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a -
Answer -New chemical entity when the sponsor has a right of reference to all applicable published
studies
A clinical investigator will conduct Phase I pharmacokinetic studies on your 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? - Answer -No
additional forms are required.
Phase I pharmacokinetic studies are not covered studies, and therefore do not need financial
certification or disclosure
A company begins to market its new device, a pacemaker (Class III) the same day that its regulatory
professional mails the Premarket Approval Application (PMA) to FDA. The pacemaker is considered: -
Answer -Adulterated
A company has submitted its NDA for review. An NDA amendment can be submitted to change or add
information to a not yet-
approved NDA. When must new safety information be submitted in a safety update report? -
Answer -Four months after the initial NDA submission (120 day safety update)
A company is developing an (unapproved) drug-device combination product but is not sure to which
center it should submit its marketing application. The company should first submit - Answer -A
Request for Designation to the Office of Combination Products
A company is planning to develop a sunscreen with an ingredient consistent with its published
monograph for marketing within the US. What type of filing does the company have to submit -
Answer -OTC Application
A company is using a clinical research organization (CRO) to develop the protocol and monitor the clinical
investigators for its
clinical trial. The regulatory professional may interact with the CRO in which of the following situations?
A Making presentations to the reviewing IRBs.
B Making presentations to the reviewing division
,C Witnessing the signing of patient consent forms
D Arranging for FDA investigators to observe treatment of subjects at clinical sites - Answer -
Making presentations to the reviewing division at FDA.
A company's supplier of the active drug substance for the company's OTC monograph drug product
informs the company that
the supplier will be moving its production of the drug substance from the current plant to a new
manufacturing plant in another state in six months. The supplier states that all manufacturing processes
will remain the same and the specifications will not change. The company intends to qualify the change
suitably. How should the company report the change to FDA? - Answer -The change does not have
to be reported because it is an OTC monograph drug
A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for
which of the following?
A Clinical testing was not performed at enough sites
B The BLA was not submitted electronically
2 C The sponsor failed to have a meeting with FDA
D The submission did not include a Drug Master File - Answer -Clinical testing was not performed
at enough testing sites.
FDA will not approve a BLA if it does not contain adequate clinical data (which may be affected by the
number of sites where testing was performed) to demonstrate safety and efficacy.
A drug manufacturer is assembling a clinical evaluation plan for a new chemical entity (NCE) to include in
an IND submission. Which of the following NCE studies DOES NOT need to be included by the
manufacturer in the clinical trial registry at www.clinicaltrials.gov?
A Phase I studies,
B Phase II studies,
C Phase III studies,
D None of the above - Answer -A
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood
donor prior to donation of a blood product. The firm should address the 510(k) submission to: -
Answer -CBER
A firm received a raw material for one of its drug products. The raw material was placed into quarantine
and sampled appropriately. Sample containers should be identified so that the following information can
be determined - Answer -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.
, A firm submitted and received approval for a clinical trial for IRB approval for a study involving children in
which there would be no prospect of direct benefit to the individual subjects. On what basis could this
study be approved by the IRB? - Answer -The trial was likely to yield generalized knowledge about
the subject's disorder or condition and all other regulatory
requirements were met.
A medical device company allows its sales force to maintain a product inventory in the field. The device
has an expiration date indicated on its labeling. A sales person notes that one of his products has expired
and contacts the headquarters office for direction. He is told to return the product to the headquarter
office for replacement. The return of this product is considered as what type of recall? - Answer -
Not a recall—it is considered normal stock rotation
A medical device company discovers that a surgeon participating as a clinical investigator in an IDE study
sponsored by the company has independently placed a video demonstrating the use of the
investigational device on YouTube.com. Should this action be considered as misbranding by the
manufacturer? - Answer -No, as long as there the surgeon makes no claims related to safety or
efficacy of the device
A medical device company is developing a product with drug, biologic and device components. The
product and indication have not been previously classified by FDA. What is the most appropriate
regulatory pathway? - Answer -A Request for Designation (RFD) should be sent to the Office of
Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the
agency with primary jurisdiction.
A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with
design control requirements. What type of submission is the manufacturer preparing to submit to FDA? -
Answer -An Abbreviated 510(k)
A medical device may be exported under Section 801(e) of the Food, Drug, and Cosmetic Act provided
that all of the following apply for the device EXCEPT:
A It is in accordance with the specifications f the receiving country,
B It is not in conflict with the laws of the recieving country ,
C It is 510k cleared or PMA approved,
D It is labeled on the outside of the shipping carton for export to the receiving country. - Answer -It
is 510(k) cleared or PMA approved
A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and
patient medication guide (MedGuide) in annotated Word format for initial FDA review, and committed to
submit the Labeling in Structured Product Label
(SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical
company to submit the SPL formatted labeling upon product approval? - Answer -14 days
with Verified Answers Download to
Score 100%
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a -
Answer -New chemical entity when the sponsor has a right of reference to all applicable published
studies
A clinical investigator will conduct Phase I pharmacokinetic studies on your 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? - Answer -No
additional forms are required.
Phase I pharmacokinetic studies are not covered studies, and therefore do not need financial
certification or disclosure
A company begins to market its new device, a pacemaker (Class III) the same day that its regulatory
professional mails the Premarket Approval Application (PMA) to FDA. The pacemaker is considered: -
Answer -Adulterated
A company has submitted its NDA for review. An NDA amendment can be submitted to change or add
information to a not yet-
approved NDA. When must new safety information be submitted in a safety update report? -
Answer -Four months after the initial NDA submission (120 day safety update)
A company is developing an (unapproved) drug-device combination product but is not sure to which
center it should submit its marketing application. The company should first submit - Answer -A
Request for Designation to the Office of Combination Products
A company is planning to develop a sunscreen with an ingredient consistent with its published
monograph for marketing within the US. What type of filing does the company have to submit -
Answer -OTC Application
A company is using a clinical research organization (CRO) to develop the protocol and monitor the clinical
investigators for its
clinical trial. The regulatory professional may interact with the CRO in which of the following situations?
A Making presentations to the reviewing IRBs.
B Making presentations to the reviewing division
,C Witnessing the signing of patient consent forms
D Arranging for FDA investigators to observe treatment of subjects at clinical sites - Answer -
Making presentations to the reviewing division at FDA.
A company's supplier of the active drug substance for the company's OTC monograph drug product
informs the company that
the supplier will be moving its production of the drug substance from the current plant to a new
manufacturing plant in another state in six months. The supplier states that all manufacturing processes
will remain the same and the specifications will not change. The company intends to qualify the change
suitably. How should the company report the change to FDA? - Answer -The change does not have
to be reported because it is an OTC monograph drug
A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for
which of the following?
A Clinical testing was not performed at enough sites
B The BLA was not submitted electronically
2 C The sponsor failed to have a meeting with FDA
D The submission did not include a Drug Master File - Answer -Clinical testing was not performed
at enough testing sites.
FDA will not approve a BLA if it does not contain adequate clinical data (which may be affected by the
number of sites where testing was performed) to demonstrate safety and efficacy.
A drug manufacturer is assembling a clinical evaluation plan for a new chemical entity (NCE) to include in
an IND submission. Which of the following NCE studies DOES NOT need to be included by the
manufacturer in the clinical trial registry at www.clinicaltrials.gov?
A Phase I studies,
B Phase II studies,
C Phase III studies,
D None of the above - Answer -A
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a
microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood
donor prior to donation of a blood product. The firm should address the 510(k) submission to: -
Answer -CBER
A firm received a raw material for one of its drug products. The raw material was placed into quarantine
and sampled appropriately. Sample containers should be identified so that the following information can
be determined - Answer -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.
, A firm submitted and received approval for a clinical trial for IRB approval for a study involving children in
which there would be no prospect of direct benefit to the individual subjects. On what basis could this
study be approved by the IRB? - Answer -The trial was likely to yield generalized knowledge about
the subject's disorder or condition and all other regulatory
requirements were met.
A medical device company allows its sales force to maintain a product inventory in the field. The device
has an expiration date indicated on its labeling. A sales person notes that one of his products has expired
and contacts the headquarters office for direction. He is told to return the product to the headquarter
office for replacement. The return of this product is considered as what type of recall? - Answer -
Not a recall—it is considered normal stock rotation
A medical device company discovers that a surgeon participating as a clinical investigator in an IDE study
sponsored by the company has independently placed a video demonstrating the use of the
investigational device on YouTube.com. Should this action be considered as misbranding by the
manufacturer? - Answer -No, as long as there the surgeon makes no claims related to safety or
efficacy of the device
A medical device company is developing a product with drug, biologic and device components. The
product and indication have not been previously classified by FDA. What is the most appropriate
regulatory pathway? - Answer -A Request for Designation (RFD) should be sent to the Office of
Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the
agency with primary jurisdiction.
A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with
design control requirements. What type of submission is the manufacturer preparing to submit to FDA? -
Answer -An Abbreviated 510(k)
A medical device may be exported under Section 801(e) of the Food, Drug, and Cosmetic Act provided
that all of the following apply for the device EXCEPT:
A It is in accordance with the specifications f the receiving country,
B It is not in conflict with the laws of the recieving country ,
C It is 510k cleared or PMA approved,
D It is labeled on the outside of the shipping carton for export to the receiving country. - Answer -It
is 510(k) cleared or PMA approved
A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and
patient medication guide (MedGuide) in annotated Word format for initial FDA review, and committed to
submit the Labeling in Structured Product Label
(SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical
company to submit the SPL formatted labeling upon product approval? - Answer -14 days
