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RAC Sample Test Exam Questions with Complete Answers
RAC Sample Test Exam Questions with Complete Answers
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RAC Sample Test Exam Questions withComplete Answers
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labeling specifications
C. Design reviews
D. Calibration records - -B. Labeling specifications
Question Feedback: Labeling specifications are part of the DMR
-A company has a new oral drug, GOODDRUG, it wishes to market in the US.
Studies on intravenous GOODDRUG have been conducted by several
academic centers demonstrating safety and efficacy and have been
published in peer-reviewed journals. The most-appropriate method to gain
approval would be by filing a:
A. ANDA
B. SNDA
C. 505(b)2
D. 505(b)1 - -C. 505(b)2
Question Feedback: Since the drug has been studied and those results
published, a comparability study between IV and oral dosage forms is
acceptable under a 505(b)2
-Your company is considering a new drug product. It has been on the market
for more than 30 years in a foreign country, but has never been approved in
the US. To sell this product in the US, you may do the following immediately
EXCEPT:
A. Determine monograph or NDA status of the product
B. Initiate clinical studies in the foreign country to support the claims since
the clinical data are old and would not meet current requirements
C. Determine whether this is a New Chemical Entity
D. Import the product and use new labeling - -D. Import the product and use
new labeling
Question Feedback: The importation of a drug product to be distributed in
the US must meet US regulations, regardless of its approved status in
another country, therefore answer 4 is correct.
-A company is developing a combination product consisting of a device that
injects a specially formulated small molecule drug for pain into the muscle
tissue. Which of the following describes the best US regulatory path:
A. The product is regulated as a drug
,B. The product is regulated under CDRH
C. The company should file a BLA to obtain US marketing approval
D. The company should submit a request for designation to OCP - -A. The
product is regulated as a drug
Question Feedback: Primary mode of action is the pain drug and the device
is a delivery system
-FDA has issued a Complete Response Letter to a company. The company
views many of the deficiencies as minor. The regulatory professional should
meet with the team to:
A. Devise a strategy for responding to all deficiencies identified by FDA
B. Devise a strategy to respond to any minor deficiencies in order to restart
the review clock
C. Inform the team a Class 1 resubmission has a six-month review clock
D. Inform the team a Class 2 resubmission has a three-month review clock -
-A. Devise a strategy for responding to all deficiencies identified by FDA
Question Feedback: Resubmissions purport to answer all of the deficiencies
needing to be addressed by the applicant prior to the original application's
approval as set forth in a previous action letter.
-A drug manufacturer creates a game-based simulation to assist diabetes
patients with management of their blood glucose levels and to motivate
them to adhere to their medication schedules. The game will be based on a
password protected website that will be made available to patients when an
FDA-approved drug is prescribed to them. How will the game most likely be
regulated by FDA?
A. It should be included as part of the NDA submission
B. It will be regulated as a Class I medical device
C. It will be regulated as an in vitro diagnostic product
D. It will not be an FDA regulated product - -D. It will not be an FDA
regulated product
Question Feedback: This type of "advertising" would fall under the category
of a "help-seeking" advertisement because the product is not named,
although it likely makes recommendations about actions that might be taken
based on a particular symptom, i.e., low or elevated glucose levels. Unlike
drug and device promotional labeling and prescription drug and restricted
device advertising, disease awareness communications are not subject to
the requirements of the FD&C Act and FDA regulations.
-For which device below does the Quality System Regulation require the
same procedures for identifying the control number for each unit, lot or
batch of finished devices as those mandated by the new UDI Rule?
A. Surgical gloves
,B. X-ray machines
C. Pacemakers
D. Syringes - -C. Pacemakers
Question Feedback: According to 21 CFR 820.65,"Each manufacturer of a
device that is intended for surgical implant into the body or to support or
sustain life and whose failure to perform when properly used in accordance
with instructions for use provided in the labeling can be reasonably expected
to result in a significant injury to the user shall establish and maintain
procedures for identifying with a control number each unit, lot, or batch of
finished devices and where appropriate components." The Pacemaker is a
Class III implantable device and subject to 21 CFR 820.65. (Sec. 820.65
Traceability- Each manufacturer of a device that is intended for surgical
implant into the body or to support or sustain life and whose failure to
perform when properly used in accordance with instructions for use provided
in the labeling can be reasonably expected to result in a significant injury to
the user shall establish and maintain procedures for identifying with a control
number each unit, lot, or batch of finished devices and where appropriate
components. The procedures shall facilitate corrective action. Such
identification shall be documented in the DHR.)
-Your company is developing a new drug to be developed and used in
combination with a cystoscopic light device for the early detection of bladder
cancer. You are asked to develop an overall regulatory strategy. The first
step you undertake is:
A. Submit a Request for Designation to FDA Office of Combination Products
for determination of the lead center for primary jurisdiction for the
combination product.
B. Make a preliminary internal company determination of the combination
product's primary mode of action.
C. Submit an IND along with a Request for Designation to FDA CDER Office of
Oncology Drug Products (OODP).
D. Submit a request for designation to FDA CDRH and notify the Office of
Combination Products - -B. Make a preliminary internal company
determination of the combination product's primary mode of action.
Question Feedback: It is important to determine the primary mode of action
first to be able to make a recommendation as to which agency component
should have primary jurisdiction, to be followed by a request for designation
to FDA OCP if deemed necessary when the product's classification or the
agency center to which it should be assigned in unclear or in dispute.
-A key pharmaceutical product parameter has a specification range of 90-
100. Which of the following postmarketing specification changes would
require FDA notification prior to making the change?
A. 89-100
, B. 90-99
C. 95 +/- 5
D. 95-100 - -A. 89-100
Question Feedback: Notification is required when the specification range is
widened. VIII. Specifications: B. Major Changes (Prior Approval Supplement)
The following are examples of changes in specifications considered to have a
substantial potential to have an adverse effect on the identity, strength,
quality, purity, or potency of a drug product as these factors may relate to
the safety or effectiveness of the drug product. C. Moderate Changes
(Supplement—Changes Being Effected) Supplement—Changes Being
Effected in 30 Days b. Relaxing an acceptance criterion
-Which of the following statements is NOT true for Phase I Investigational
New Drug (IND) Applications and Investigational Device Exemptions (IDEs)
for significant-risk products?
A. The investigational product must be manufactured in full compliance with
CGMP
B. Clinical study protocols must be reviewed and approved by an Institutional
Review Board
C. The IND or IDE goes into effect 30 days after FDA receives the application,
unless FDA notifies the sponsor otherwise
D. The application must include an environmental impact statement that
contains a claim for categorical exclusion or an environmental assessment -
-A. The investigational product must be manufactured in full compliance with
CGMP
Question Feedback: According to CFR 210, 2(c), "An investigational drug for
use in a phase 1 study, as described in 312.21(a) of this chapter, is subject
to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The
production of such drug is exempt from compliance with the regulations in
part 211 of this chapter." However, based on FDA guidance, Phase 1
investigational drugs should be manufactured with the application of some
(not full) CGMP.
-What type of communication will FDA send an applicant when the review
division concludes an NDA or ANDA cannot be approved in its present form
and certain additional information or clarifications are needed?
A. Non-approvable letter
B. Complete response letter
C. Non-approval letter
D. Approvable letter - -B. Complete response letter
Question Feedback: All deficiencies identified by FDA will be in the complete
response letter. The letter also will reflect the review of the entire application
and/or amendments submitted.
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