RAC Exam I Test Questions

Question 1 of 100
In conformance with GMP, which of the following departments is responsible for
approving or rejecting final products?

A. Regulatory affairs
B. Quarantine and inspection
C. Quality control
D. Operations
Question 2 of 100
Which of the following federal laws includes information about ANDA
submissions?

A. Antibiotic Amendments of 1945

B. Durham-Humphrey Amendment of 1951
C. Drug Amendments of 1962
D. Drug Price Competition and Patent Term Restoration Act of 1984
Question 3 of 100
A company wants to modify its device such that there is a major change to
the fundamental scientific technology of the device. The FDA has published
a guidance on this technology and special controls have been established.
This change would be best filed as a(n):

A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA
Question 4 of 100
The following is exempt from the requirements for providing a true
statement of information in brief summary relating to side effects,
contraindications and effectiveness:

A. Broadcast advertising
B. Professional labeling
C. Reminder advertising
D. Direct-to-consumer advertising
Question 5 of 100
Removal of a distributed product for a reason NOT subject to legal action by
FDA is known as:

A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action
Question 6 of 100
Which of the following documentation is NOT included in a Biologics License
Application?

A. Stability data
B. Product labeling
C. GLP compliance statements (included in the tox reports)
D. Overall quality summary
Question 7 of 100
Distribution records for drug products must reference or contain all of the
following EXCEPT:

A. Name and address of the consignee

B. Name, strength of the product and description of the dosage form
C. Lot or control number and date quantity shipped
D. Purchase order number and date ordered
Question 8 of 100
When assembling an NDA, all of the following is required EXCEPT:

A. Proposed labeling
B. Nonclinical toxicology studies
C. Bioequivalence studies
D. Manufacturing information
Question 9 of 100
Which of the following is NOT true regarding 21 CFR Part 11?

A. Applies to records in electronic form that are created, modified,

maintained and archived for regulatory reasons
B. Applies to all electronic records submitted to FDA under the FD&C Act
C. Part 11 will be interpreted narrowly
D. Predicate rule record and record keeping requirements are optional
Question 10 of 100
MDUFMA authorized 3rd party establishment inspections. All of the
following are true about these inspections EXCEPT:

A. You need to market at least one device in the United States (sponsor)
B. Participation is voluntary
C. In order to be eligible, an establishment's most recent inspection must be
NAI or VAL
D. Establishments are not required to obtain clearance of a 3rd party in
advance
Question 11 of 100
If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper use by the end user, which
of the following typically occurs?

A. The labeling is revised

B. The product is recalled
C. The product is redesigned
D. A "Dear Doctor" letter is issued
Question 12 of 100
Which information MUST be included in an IND?

A. A list of all components used in the manufacture of the investigational

drug product
B. A statement of compliance with applicable GMPs
C. Statistical methods to be used in the analysis of phase II and III clinical
trials
D. Results of accelerated stability studies on three lots of the investigational
drug product
Question 13 of 100
Failure of a device manufacturer to notify FDA under paragraph 510(k) of
the FD&C Act before marketing a device:

A. Makes the product misbranded under Section 502 of the Act

B. Introduces an unapproved product into interstate commerce
C. Causes the product to be mislabeled
D. None of the above
Question 14 of 100
The marketing department has designed a journal advertisement which
mentions the leadership in a particular therapeutic area and includes only
the name of the company‘s approved prescription drug products. Which of
the following should be included in the advertisement to be in compliance
with regulations?

A. Full prescribing information

B. A brief summary of the prescribing information
C. References to clinical data
D. A complete listing of adverse events
Question 15 of 100
Inspections of device components received from a supplier may frequently
reveal product quality deficiencies. To avoid these instances, the supplier
should first have:

A. Expert GMP knowledge

B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
D. An internal audit program
Question 16 of 100
Which is true about electronic submissions?

A. If you file an eCTD, all subsequent amendments to the marketing

application must be electronic
B. The FDA does not have a preferred format/file structure for e-submissions
C. Only NDAs may be submitted electronically
D. All FDA divisions accept electronic submissions
Question 17 of 100
Under the Medical Device Quality System Regulation, device design
requirements MUST meet the needs of the:

A. Manufacturer
B. Patient
C. User
D. Patient and user
Question 18 of 100
All of the following are requirements of an IRB EXCEPT that it:

A. Has at least five members

B. Includes at least one non-scientific member
C. Obtains informed consent from all subjects
D. Represents the cultural mix of the community
Question 19 of 100
Subacute toxicity testing should be performed:

A. In two rodent species

B. In one rodent and one non-rodent species
C. For a minimum of two weeks
D. For a minimum of six months
Question 20 of 100
Which of the following is NOT TRUE regarding post-approval
pharmacovigilance for a drug?

A. It is intended to detect all medically important adverse effects and

uncommon safety risks in the "real world" of clinical practice
B. Health professionals report all adverse drug reactions associated with the
use of a marketed drug
C. Adverse effects from products in the same pharmacologic class as the
marketed drug must be considered along with those for the marketed drug
D. Serious and unexpected adverse drug reactions in patients treated
outside the United States need to be filed within 15 days after initial
notification
Question 21 of 100
While examining complaint files, a quality assurance practitioner 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?

A. Sterilization and water system validations

B. Environmental monitoring
C. Raw material/supplier records
D. Batch or product history record
Question 22 of 100
A defective product was released into distribution and has caused patient
injuries. The patients were treated in a local hospital and may suffer further
reversible medical consequences as a result of the defective product. If this
product is recalled from the market, which of the following recall
classifications would most likely be assigned?

A. Class I
B. Class II
C. Class III
D. Class IV
Question 23 of 100
Which of the following is NOT true regarding ANDAs filed under paragraph IV
certification?

A. They allow companies to seek approval of an ANDA before the expiration

date of the patent for the reference drug
B. The first company to receive approval of the ANDA has exclusive marketing
rights for 180 days
C. Notification of the ANDA submission to the original patent holder is not
required at the time of submission
D. Patent holders have 45 days to file an infringement suit against the filer
Question 24 of 100
When the proprietary name or designation is used in promotion, the
following is TRUE:

A. The proprietary name or designation can, in certain instances, be used

without the accompaniment of the established name
B. The established name shall be printed in letters that are at least half as
large as the letters comprising the proprietary name or designation with
which it is joined
C. The established name shall be printed in letters that are at least 1/4 as
large as the letters comprising the proprietary name or designation
D. The proprietary name or designation must be printed in letters at least
twice as large as the established name
Question 25 of 100
Which of the following is NOT a responsibility of clinical investigators?

A. Submitting notices to the IRB of deviations from the investigational plan

B. Maintaining records of receipt, use and disposition of investigational
product
C. Reporting to the sponsor withdrawal of IRB approval
D. Submitting unanticipated adverse event reports to FDA
Question 26 of 100
Under the IDE regulation, all of the following must be reported to the
sponsor within five working days EXCEPT:

A. A deviation from the investigational plan

B. Withdrawal of IRB approval
C. An unanticipated adverse device effect
D. Use of a device without informed consent
Question 27 of 100
In preparing the list of components of a drug product to include in an NDA,
the regulatory affairs practitioner should submit:

A. The list of all active ingredients, antimicrobial preservatives and

antioxidiants, with their pharmaceutical grades and the names of the
suppliers
B. Drug Master File referral letters from each supplier of active ingredients,
antimicrobial preservatives and antioxidiants
C. GMP Certifications from the suppliers of all active ingredients excipients
D. The list of all components used in the manufacture of the drug product,
regardless of whether they appear in the drug product
Question 28 of 100
A company has received a 10-page FDA-483. The regulatory affairs
professional's supervisor has prepared a detailed response assuring the FDA
district office that corrective action has been taken for each observation.
Which of the following should be done?

A. Re-audit the company's corrective actions before the letter is sent

B. Re-audit the company's corrective actions within three months because
FDA usually conducts
C. Re-audit the company's corrective actions during the next scheduled audit
D. Re-audit the company's corrective actions immediately after the letter is
sent
Question 29 of 100
Which of the following changes require FDA approval of NDA supplements
before the change is made?

A. Adding an additional test method

B. Deleting a dye from the drug product
C. Making changes that comply with USP
D. Relaxing the limits for a drug substance specification
Question 30 of 100
A marketing department plans to launch a series of educational speaker's
programs for one of the company's drug/biologic products. Which of the
following statements is a regulation that applies to promotional activities?

A. Adequate and well-controlled studies are required to substantiate all

conclusions presented
B. The company may suggest speakers or content for the presentations
C. An independent third-party organization must manage the seminar series
D. All speakers must disclose any financial relationships with the sponsoring
company
Question 31 of 100
Which of the following must file an IDE before conducting a human clinical
study?

A. A device in commercial distribution before May 28, 1976 when used or

investigated in accordance with its indications in labeling in effect at that
time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness
D. A and B
Question 32 of 100
FDA defines a label as that which is affixed to the:

A. Carton
B. Shrink wrapper
C. Shipping package
D. Immediate container
Question 33 of 100
Which of the following sections is required in a PMA?

A. Patent certification information

B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations
Question 34 of 100
Which of the following is true about DMFs?

A. DMFs are not reviewed until referenced by a marketing application

B. DMFs do not require annual updates
C. The only types of DMFs recognized by the FDA are Type I, Type II and Type III
D. A sponsor does not need written permission to reference a DMF
Question 35 of 100
Which of the following manufacturers must register their manufacturing
facility with FDA?

A. Component manufacturers who sell only to the device manufacturer

using their components
B. Domestic (US) contract manufacturers who do not directly distribute the
final product to the market
C. Domestic manufacturer of device being investigated under an IDE
D. Foreign manufacturers shipping devices into the US for sale in the US
Question 36 of 100
Which type of protocol is NOT eligible for a Special Protocol Assessment
under the PDUFA?

A. Animal carcinogenicity study protocol

B. Phase 3 clinical protocol where data from the primary basis for an efficacy
claim
C. Final product stability study protocol
D. Bioequivalence study protocol
Question 37 of 100
Which of the following is exempt from GMP/QS regulations?

A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Question 38 of 100
To avoid the potential for cross-contamination, FDA requires the
manufacture of penicillin products to be:

A. In a building separated from other manufacturing buildings

B. In plants that are inspected quarterly
C. In a dedicated and validated isolation facility
D. Under laminar flow protection that is validated periodically
Question 39 of 100
The following is NOT TRUE regarding the recall of a product from the market
that is deemed to be in violation of FDA laws:

A. The classification for a recall (I, II, III) is assigned by the FDA
B. A Class I recall is for the highest level of risk associated with use of, or
exposure to, a defective product
C. FDA can mandate a company to recall its marketed product
D. A recall is intended to protect the consumer
Question 40 of 100
With respect to drug product distribution procedures, a distributor is
required to do all of the following EXCEPT:

A. Establish a system whereby the oldest approved stock of a drug is

distributed last
B. Establish written procedures describing the distribution of drug products
C. Establish a system whereby the oldest approved stock of a drug is
distributed first
D. Establish a system by which the distribution of each lot can readily be
tracked and the lot recalled, if necessary
Question 41 of 100
A medical device is refused entry to the US. All of the following may be
reasons for refusal EXCEPT for the lack of:

A. Establishment registration by the foreign manufacturer

B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor
Question 42 of 100
Premarket Notification is required of manufacturers when introducing:

A. New label size

B. New Class II devices
C. A change in product name
D. Additional manufacturing sites
Question 43 of 100
Which of the following subsystems is NOT required by FDA in order to
implement and maintain a Quality System?

A. Production and process controls

B. Test and control article characterization
C. Packaging and labeling controls
D. Buildings and facilities
Question 44 of 100
A regulatory affairs professional wants to schedule a pre-NDA meeting with
the FDA. He or she should:

A. Write a letter to the FDA

B. Request a Type B meeting as an amendment to the IND
C. Call the project manager and set up a date over the phone
D. Email the division director with a list of three dates, 30 days into the future
Question 45 of 100
The clinical research department has identified a new indication for one of
the company‘s marketed drugs based on efficacy in preclinical models. The
formulation for the drug product and the route of administration would be
different. As the regulatory affairs professional, you should set up a meeting
to discuss the regulatory path forward with which of the following
departments in your company?

A. Only the regulatory department is needed to decide the regulatory path

forward
B. Regulatory, clinical and toxicology departments
C. Regulatory, clinical, toxicology, manufacturing and marketing departments
D. Regulatory, clinical, toxicology, manufacturing, marketing and shipping and
receiving departments
Question 46 of 100
The Freedom of Information Act allows a manufacturer to:

A. Make claims about a product already commercially available

B. Obtain QC methods on a competitor's product
C. Obtain the Drug/Device Master File of a competitor's product
D. Obtain public documents on another manufacturer's product
Question 47 of 100
Fully quality-assured individual toxicology reports are not required for
submission of an initial IND application. However, finalized and updated
reports should be available to FDA upon request within what period of the
start of the human study?

A. 90 days
B. 120 days
C. One year
D. The final report is only required in the submission for the NDA
Question 48 of 100
According to the drug regulations, the FDA will most likely put an IND on
clinical hold for which of the following reasons:

A. Human subjects are exposed to a reasonable degree (non-significant) or

risk of illness or injury by participating in the trail
B. The manufacturer charges a fee for the investigational product
C. The clinical investigators are qualified by scientific training or experience
to conduct the study described in the investigator's brochure
D. The sponsor is not pursuing marketing approval with due diligence
Question 49 of 100
A physician reports to a manufacturer that a patient was hospitalized with
acute sepsis after treatment with an approved device. This side effect is not
listed in the package insert. This event must be reported by the
manufacturer to FDA no later than:

A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report
Question 50 of 100
All of the following are required for compliance to 21 CFR Part 11 (electronic
records and electronic signatures) EXCEPT:

A. Manually generated, time-stamped audit trails to record the date and

time of operator entries and actions
B. Validation of systems to ensure accuracy, reliability, consistent intended
performance and the ability to discern invalid or altered records
C. Authority checks to ensure that only authorized individuals can use the
system, electronically sign a record, access the operation or computer
system input or output device, alter a record or perform the operation at
hand
D. Establishment of, and adherence to, written policies that hold individuals
accountable and responsible for actions initiated under their electronic
signatures, in order to deter record and signature falsification
Question 51 of 100
A personal deodorant manufacturer is required to do all of the following
EXCEPT:

A. Comply with GMP

B. State the place of business on the label
C. List the quantity of contents on the label
D. Comply with export regulations when exporting product
Question 52 of 100
Which one of the following statements is NOT true with respect to both
Investigational New Drug Applications (INDs) and Investigational Device
Exemptions (IDEs) for significant-risk products?

A. The investigational product must be manufactured in full compliance with

cGMP
B. Clinical studies must be 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
Question 53 of 100
A regulatory affairs professional is developing SOPs for a firm to cover
compliance with drug GMPs. The firm's SOPs should require failure
investigations to be completed within:

A. A reasonable time
B. 20 days
C. 30 days
D. 45 days
Question 54 of 100
A product storage and handling system for medical devices must always
include:

A. Procedures for rotation of stock

B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life
Question 55 of 100
Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:

A. Providing a final study report to the IRB

B. Protecting the rights, safety and welfare of study subjects
C. Controlling the test materials under investigation during the study
D. Keeping all of the unused test material at their facility until the
drug/device is approved by the FDA
Question 56 of 100
All of the following are considered General Controls under the Food, Drug &
Cosmetic Act EXCEPT:

A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device
Question 57 of 100
Which of the following is NOT TRUE for an FDA inspection of a facility that
manufactures a small molecule drug?

A. A notice of inspection (FDA 482 form) is presented by the FDA investigator

on arrival at the facility
B. The credentials of the FDA investigator can be photocopied for filing at
the facility
C. The FDA investigator provides inspectional findings on a FDA 483 form
D. The FDA investigator provides an FDA 484 form to describe samples taken
during the inspection
Question 58 of 100
According to the Quality System Regulation, suitable maintenance of
equipment is necessary to ensure that manufacturing specifications are met.
All of the following are requirements for the equipment EXCEPT:

A. A written maintenance schedule is required

B. Allowable tolerances are posted on or near the equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented
Question 59 of 100
A company's competitor is marketing a Class II suture which dissolves during
the third week of use. The company's current product has to be removed by
a physician. However, a change in weaving configuration gives this product
the same dissolving time as the competitor's. When can the company's new
suture be marketed?

A. This requires a new 510(k) since significant change in product instructions

might effect efficacy
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change
Question 60 of 100
Which of the following does NOT discuss the protection of human subjects?

A. Nuremberg Code
B. Declaration of Helsinki
C. Drug Amendment of 1962
D. Food Drug and Cosmetic Act of 1938
Question 61 of 100
According to the Quality System Regulations, re-testing and re-evaluation of
nonconforming devices after rework activities must be documented in the:

A. Device history record

B. Device master record
C. Complaint files
D. Design history file
Question 62 of 100
In the development of a revised manufacturing procedure, which of the
following is a critical step in ensuring that the product manufactured would
not be adversely affected by this change?

A. Procedure qualification
B. Product verification and/or process validation
C. Quality control
D. Conformance inspection
Question 63 of 100
What additional FDA clearances are required to export a drug approved by
FDA?

A. Certificate of Free Sale

B. Customs Tax Stamps
C. No clearance required
D. FDA receipt for sample Form-484
Question 64 of 100
During a review of an internal audit, the auditor discovers a product being
manufactured consisting of a battery-operated toothbrush impregnated
with non-fluoridated toothpaste. There are no controls for the manufacture
of the finished product. Compliance with which of the following is required
for the manufacture of this product?

A. Device QSR regulations

B. Drug GMP regulations
C. Cosmetic GMP regulations
D. No controls required
Question 65 of 100
A company has been given a product from its British subsidiary to market for
the first time in the US. The product is marketed in the EU. A project team
gathered by the regulatory professional to review the information available
for regulatory submission to FDA should:

A. Focus on labeling and marketing since mutual recognition does not

require complete technical review
B. Include production, marketing, QA and clinical research for a thorough
review
C. Summarize financial data and distribution data which are normally
required to be submitted to FDA
D. Not be necessary if a Common Technical Document has been prepared by
the subsidiary
Question 66 of 100
The protocol for a non-clinical laboratory study must contain all of the
following EXCEPT:

A. The species, strain and age of the test system

B. The dated signature of the sponsor representative
C. A description of the methods for the control of bias
D. The type and frequency of tests and measurements
Question 67 of 100
Which of the following is NOT TRUE for a Memorandum of Understanding
(MOU)?

A. MOUs clarify the regulatory responsibilities between the FDA and other
federal agencies
B. MOUs delineate roles and authority of the FDA and state governments
C. New MOUs are announced in the Federal Register
D. MOUs describe the inspection procedures used by agencies working in
collaboration with the FDA
Question 68 of 100
When design verification testing is being performed by a manufacturer,
which element is NOT included as a potential requirement under device
design verification section of the QSR?

A. Identification of the design

B. Software validation
C. Identification of test methods used
D. Name of individuals performing the testing
Question 69 of 100
During a monitoring visit, the sponsor discovers that an investigator had
used a device in a clinical investigation without obtaining informed consent
from the subject. Which of the following should the regulatory affairs
professional do?

A. Predate the informed consent with a memo to the site file

B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director from the sponsor discusses the issue with
the investigator
D. Report the protocol deviation to the IRB
Question 70 of 100
A 510(k) submission for any Class III device MUST include:

A. Clinical results summary

B. Hazards analysis evaluation
C. Stability evaluation
D. Certification and summary
Question 71 of 100
FDA may perform a pre-approval inspection of an applicant's manufacturing
facility before approving an application. The filing of which of the following
submissions does NOT automatically activate the consideration of a pre-
approval inspection?

A. New Drug Application

B. Abbreviated New Drug Application
C. Pre-Market Approval Application
D. Drug/Device Master File
Question 72 of 100
A legally marketed device to which equivalence is drawn in a premarketing
submission is known as the:

A. Market comparator device

B. Placebo device
C. Predicate device
D. Substantially equivalent device
Question 73 of 100
The Quality System Regulation calls for the manufacturer of finished devices to
carry out all of the following EXCEPT:

A. Conduct quality audits by individuals who do not have direct responsibility

for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited
Question 74 of 100
Which division would have a primary jurisdiction over a vascular graft with
an antibiotic based on primary mode of action?

A. CDER
B. CBER
C. CDRH
D. OCP
Question 75 of 100
A humanitarian device exemption (HDE) differs from a traditional PMA in
that:

A. It does not require compliance with QSR

B. Non-clinical data are not required
C. Effectiveness data are not required
D. Device characteristics are not required
Question 76 of 100
A company's supplier of the active drug substance for the company's OTC
drug product informs the company that the supplier will be moving their
production of the drug substance from the current plant to a new
manufacturing plant in another state in 6 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?

A. The change only needs to be reported in an annual report because the

company will qualify the change and the supplier said the process and
specification won't change
B. The change should be reported in a pre-approval supplement (e.g., CBE,
CBE-30 or full pre-approval supplement) because it is a change to the drug
substance manufacturing location
C. The change does not have to be reported because it is an OTC drug
D. Not enough information
Question 77 of 100
In order to ensure that a facility complies with GMP requirements, all of the
following features should be evaluated EXCEPT:

A. Air handling system

B. Animal supply facilities
C. Lighting
D. Potable water
Question 78 of 100
Under the statutory violations, lack of an approved PMA for a PMA device
that is not exempt and is in commercial distribution is considered to be:

A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
Question 79 of 100
To be legally effective, a witness must observe the informed consent process
at which of the following times?

A. When the study subject is a minor

B. When the elements of informed consent are presented orally
C. When the consent is obtained from the subject's legal representative
D. When the elements of informed consent are written in a foreign language
Question 80 of 100
Which of the following is NOT true of an Advisory Committee?

A. Advisory Committee meetings can include an oral presentation from a

patient advocacy group
B. Advisory Committee members are selected without regard to race,
ethnicity, sex, age or religion
C. Advisory Committees provide advice to FDA on safety and effectiveness of
drugs
D. Advisory Committees recommend whether a drug should be approved
and do not provide advice on product labeling or clinical trial design
Question 81 of 100
MDUFMA authorizes FDA-accredited persons to inspect qualified
manufacturers of:

A. Class I and II devices

B. Class I devices only
C. Class II devices only
D. Class II and III devices
Question 82 of 100
All of the following are additional IND submissions to FDA EXCEPT:

A. Information amendments
B. Protocol deviations
C. IND safety reports
D. Annual reports
Question 83 of 100
FDA will do a for-cause inspection of an investigator if the investigator:

A. Conducts a number of pivotal NDA studies

B. Is only participating in a small number of studies
C. Appears to have an excessive number of study projects
D. Consistently reports results different from other investigators
Question 84 of 100
An IRB will NOT review:

A. Risks and benefits of the proposed research

B. Risks and benefits of alternative therapies
C. Prospective informed consent document
D. Provisions to protect the privacy of subjects
Question 85 of 100
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
Question 86 of 100
A company has found a way to produce its drug product more
economically; however, the current manufacturing process would have to
be changed substantially. What would be the most appropriate post-
approval vehicle for this potential action?

A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0)

B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30)
C. Prior approval supplement
D. Annual report
Question 87 of 100
A company is using a clinical research organization (CR0) to develop the
protocol and monitor the clinical investigators for the company's clinical
trial. The regulatory affairs professional may interact with the CR0 in which
of the following situations?

A. Making presentations to the reviewing IRBs

B. Making presentations to the reviewing division at FDA
C. Witnessing the signing of patient consent forms
D. Arranging for FDA investigators to observe treatment of subjects at clinical
sites
Question 88 of 100
The difference between advertising and professional labeling is that:

A. Advertising can be directed to only consumers and professional labeling

can be directed to only professionals
B. Advertising must be accompanied by a PI while professional labeling must
be accompanied by a brief summary
C. Advertising can be directed to either consumers or professionals while
professional labeling can be directed to only consumers
D. Advertising must be accompanied by a brief summary and professional
labeling must be accompanied by a PI
Question 89 of 100
At what interval are quality assurance audits conducted for nonclinical
studies lasting more than six months?

A. One month
B. Quarterly
C. At completion
D. Periodically
Question 90 of 100
Under whose authority can an imported drug, device or biologic be detained
or refused entry into the US?

A. U.S Department of Agriculture

B. U.S Customs
C. FDA
D. FBI
Question 91 of 100
A minimum of 10 tablets is required to perform all tests for product release.
To meet GMP requirements, retention samples must be at least:

A. 10 tablets
B. 20 tablets
C. 30 tablets
D. 100 tablets
Question 92 of 100
Due to mechanical failure, a product line has remained in process for five
days over the time limit established in the company's SOPs. Which of the
following should be done first?

A. Reject the product since the time limit has been exceeded
B. Proceed with processing and quarantine the product
C. Complete the manufacturing process and ship the product
D. Have the appropriate department investigate and prepare a deviation
report and document all events
Question 93 of 100
FDA has sent a warning letter citing mislabeling of a small manufacturer's
artificial knee device. The regulatory affairs professional should first contact the:

A. Compliance Branch in the district

B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation
C. Division of Small Manufacturers Assistance in CDRH
D. CDRH Ombudsman
Question 94 of 100
Because of reported dispensing errors due to the similarity of proprietary
drug names, one of the companies involved has decided to quickly and
voluntarily notify physicians and others responsible for providing patient care
about the issue via a "Dispensing Error Alert". In this approach, the company
is NOT required to:

A. Use first class mail and number 10 white envelopes

B. Use appropriate language on the outside of the mailing envelope which
indicates the nature of the alert
C. Notify FDA of it's action prior to disseminating the dispensing alert
notification
D. Include it's name and address in the upper left hand corner of the
envelope
Question 95 of 100
The regulatory affairs professional performs all of the following prior to
submitting a PMA to FDA EXCEPT:

A. Preparing criteria for the MDR report

B. Preparing a brief statement of reasons for noncompliance with regulation
C. Identifying all omissions in PMA content
D. Reviewing, organizing and checking adequacy of data pertaining to safety
and efficacy evaluation
Question 96 of 100
A sponsor submitted an original IDE/IND application. If the sponsor has not
received any response from the FDA, what is the earliest that clinical studies
can be initiated?

A. The sponsor must wait for FDA approval

B. Upon IRB approval from any study center
C. 30 days from receipt by FDA
D. 90 days from receipt by FDA
Question 97 of 100
A GMP audit/inspection against the requirements of 21 CFR 2 10/211 may
include auditing of all of the following EXCEPT:

A. Complaint files
B. Qualifications of consultants
C. Pre-clinical laboratory(ies)
D. SOPs
Question 98 of 100
The initial importer of a medical device MUST:

A. Register and submit device list to FDA

B. Maintain quality assurance files
C. Share responsibility for submittals with other distributors
D. Report device malfunctions in an annual report
Question 99 of 100
Which of the following devices are not subject to requirements for Design
Controls?

A. Class I devices
B. Class II devices
C. Class III devices
D. None of the above
Question 100 of 100
During an audit of a manufacturing site, the FDA inspector learns that
complaints from the field are not being adequately documented. At the
closing meeting, the FDA inspector presents:

A. Establishment Inspection Report (EIR)

B. Establishment Registration Report (ERR)
C. Summary of Inspectional Findings (FD-481)
D. List of Observations (FD-483)