RAC Practice Exam 1 Questions With Complete Solutions
A 505(b)(2) NDA is not an appropriate regulatory submission
for the approval to market a Correct 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?
Correct 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: Correct 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? Correct 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 Correct 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 Correct 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 Correct 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? Correct
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 Correct
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 Correct 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: Correct Answer
CBER
A 505(b)(2) NDA is not an appropriate regulatory submission
for the approval to market a Correct 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?
Correct 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: Correct 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? Correct 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 Correct 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 Correct 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 Correct 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? Correct
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 Correct
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 Correct 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: Correct Answer
CBER
