RAC Exam I Test Questions
The RAC Exam I Test Questions cover various aspects of regulatory affairs and compliance in the pharmaceutical industry. The questions touch on topics such as GMP, FDA regulations, product approvals, and legal requirements. Test your knowledge with these 100 questions to enhance your understanding of regulatory practices in pharmaceuticals.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
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
