Practice Exam

Question 1

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

Answer 1

C. Quality control

Question 2

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

Answer 2

D. Drug Price Competition and Patent Term Restoration Act of 1984

Question 3

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

Answer 3

C. Traditional 510(k)

Question 4

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

Answer 4

C. Reminder advertising

Question 5

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

Answer 5

C. Market withdrawal

Question 6

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

Answer 6

C. GLP compliance statements (included in the tox reports)

Question 7

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

Answer 7

D. Purchase order number and date ordered

Question 8

When assembling an NDA, all of the following is required EXCEPT:

A. Proposed labeling
B. Nonclinical toxicology studies
C. Bioequivalence studies
D. Manufacturing information

Answer 8

C. Bioequivalence studies

Question 9

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

Answer 9

C. Part 11 will be interpreted narrowly

Question 10

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

Answer 10

D. Establishments are not required to obtain clearance of a 3rd party in advance

Question 11

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

Answer 11

D. A “Dear Doctor” letter is issued

Question 12

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

Answer 12

C. Statistical methods to be used in the analysis of phase II and III clinical trials

Question 13

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

Answer 13

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

Question 14

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

Answer 14

B. A brief summary of the prescribing information

Question 15

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

Answer 15

B. Clear and precise specifications from the manufacturer

Question 16

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

Answer 16

A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic

Question 17

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

Answer 17

C. User

Question 18

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

Answer 18

C. Obtains informed consent from all subjects

Question 19

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

Answer 19

C. For a minimum of two weeks

Question 20

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

Answer 20

B. Health professionals report all adverse drug reactions associated with the use of a marketed drug

Question 21

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

Answer 21

A. Sterilization and water system validations

Question 22

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

Answer 22

B. Class II

Question 23

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

Answer 23

C. Notification of the ANDA submission to the original patent holder is not required at the time of submission

Question 24

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

Answer 24

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

Question 25

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

Answer 25

D. Submitting unanticipated adverse event reports to FDA

Question 26

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

Answer 26

C. An unanticipated adverse device effect

Question 27

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

Answer 27

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

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

Answer 28

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

Question 29

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

Answer 29

D. Relaxing the limits for a drug substance specification

Question 30

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

Answer 30

D. All speakers must disclose any financial relationships with the sponsoring company

Question 31

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

Answer 31

C. A custom device being studied for safety and effectiveness

Question 32

FDA defines a label as that which is affixed to the:

A. Carton
B. Shrink wrapper
C. Shipping package
D. Immediate container

Answer 32

D. Immediate container

Question 33

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

Answer 33

D. A discussion of benefit and risk considerations

Question 34

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

Answer 34

B. DMFs do not require annual updates

Question 35

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

Answer 35

D. Foreign manufacturers shipping devices into the US for sale in the US

Question 36

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

Answer 36

D. Bioequivalence study protocol

Question 37

Which of the following is exempt from GMP/QS regulations?

A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers

Answer 37

D. Component manufacturers

Question 38

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

Answer 38

A. In a building separated from other manufacturing buildings

Question 39

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

Answer 39

B. A Class I recall is for the highest level of risk associated with use of, or
exposure to, a defective product

Question 40

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

Answer 40

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

Question 41

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

Answer 41

D. Establishment registration by the initial distributor

Question 42

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

Answer 42

B. New Class II devices

Question 43

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

Answer 43

D. Buildings and facilities

Question 44

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

Answer 44

B. Request a Type B meeting as an amendment to the IND

Question 45

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

Answer 45

C. Regulatory, clinical, toxicology, manufacturing and marketing departments

Question 46

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

Answer 46

D. Obtain public documents on another manufacturer’s product

Question 47

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

Answer 47

B. 120 days

Question 48

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

Answer 48

D. The sponsor is not pursuing marketing approval with due diligence

Question 49

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

Answer 49

C. 30 calendar days

Question 50

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

Answer 50

A. Manually generated, time-stamped audit trails to record the date and time of operator entries and actions

Question 51

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

Answer 51

A. Comply with GMP

Question 52

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

Answer 52

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

Question 53

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

Answer 53

A. A reasonable time

Question 54

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

Answer 54

C. Procedures for receipt and transfer of product

Question 55

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

Answer 55

D. Keeping all of the unused test material at their facility until the drug/device is approved by the FDA

Question 56

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

Answer 56

B. Premarket approval application

Question 57

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

Answer 57

B. The credentials of the FDA investigator can be photocopied for filing at the facility

Question 58

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

Answer 58

C. Maintenance must be performed at least annually

Question 59

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

Answer 59

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

Question 60

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

Answer 60

D. Food Drug and Cosmetic Act of 1938

Question 61

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

Answer 61

A. Device history record

Question 62

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

Answer 62

B. Product verification and/or process validation

Question 63

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

Answer 63

C. No clearance required

Question 64

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

Answer 64

A. Device QSR regulations

Question 65

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

Answer 65

B. Include production, marketing, QA and clinical research for a thorough review

Question 66

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

Answer 66

B. The dated signature of the sponsor representative

Question 67

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

Answer 67

D. MOUs describe the inspection procedures used by agencies working in collaboration with the FDA

Question 68

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

Answer 68

B. Software validation

Question 69

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

Answer 69

C. Ensure that the study director from the sponsor discusses the issue with the investigator

Question 70

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

Answer 70

D. Certification and summary

Question 71

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

Answer 71

D. Drug/Device Master File

Question 72

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

Answer 72

C. Predicate device

Question 73

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

Answer 73

B. Audit operations annually

Question 74

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

Answer 74

C. CDRH

Question 75

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

Answer 75

C. Effectiveness data are not required

Question 76

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

Answer 76

B or D?

Question 77

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

Answer 77

B. Animal supply facilities

Question 78

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

Answer 78

A. Adulteration

Question 79

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

Answer 79

B. When the elements of informed consent are presented orally

Question 80

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

Answer 80

D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design

Question 81

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

Answer 81

D. Class II and III devices

Question 82

All of the following are additional IND submissions to FDA EXCEPT:

A. Information amendments
B. Protocol deviations
C. IND safety reports
D. Annual reports

Answer 82

B. Protocol deviations

Question 83

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

Answer 83

D. Consistently reports results different from other investigators

Question 84

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

Answer 84

B. Risks and benefits of alternative therapies

Question 85

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

Answer 85

D. Ensure the adequacy of the IRB and its procedures

Question 86

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

Answer 86

C. Prior approval supplement

Question 87

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

Answer 87

B. Making presentations to the reviewing division at FDA

Question 88

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

Answer 88

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI

Question 89

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

Answer 89

D. Periodically

Question 90

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

Answer 90

B. U.S Customs

Question 91

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

Answer 91

B. 20 tablets

Question 92

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

Answer 92

B. Proceed with processing and quarantine the product

Question 93

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

Answer 93

A. Compliance Branch in the district

Question 94

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

Answer 94

C. Notify FDA of it’s action prior to disseminating the dispensing alert notification

Question 95

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

Answer 95

A. Preparing criteria for the MDR report

Question 96

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

Answer 96

C. 30 days from receipt by FDA

Question 97

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

Answer 97

B. Qualifications of consultants

Question 98

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

Answer 98

D. Report device malfunctions in an annual report

Question 99

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

Answer 99

A. Class I devices

Question 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)

Answer 100

D. List of Observations (FD-483)