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Answer: A Question: 112 Which of the following supplements to an approved NDA/BLA must be approved by FDA prior to distributing product made using the change? A. Make change(s) to comply with USP B. Change in the technical grade of an excipient, same specifications and use C. Add a warning statement...

Answer: A Question: 112 Which of the following supplements to an approved NDA/BLA must be approved by FDA prior to distributing product made using the change? A. Make change(s) to comply with USP B. Change in the technical grade of an excipient, same specifications and use C. Add a warning statement to prescribing information D. Process change outside the validated range Answer: D Question: 113 The Quality System Regulation (QSR) for medical devices regarding Design Controls require which of the following: A. Documentation of early research of the design B. Design and development plans address how design inputs and requirements are managed C. A product design can be outsourced by a manufacturer so they do not have to maintain the documentation D. Design activities are only required for Class III Investigational devices Answer: A Question: 114 GLP documentation archives should have the following attributes except: A. Appropriate for laboratory specimens B. Accessible to all facility personnel C. Environmentally controlled (temperature and humidity) D. Secure with controlled access to raw data and documentation Answer: A Question: 115 Visit us at Standard operating procedures should be generated for the following GLP activities except: A. Animal Care B. Laboratory Tests C. Data Handling, Storage and Retrieval D. Management of Publications Answer: D Question: 116 Which is a type of administrative enforcement tool that FDA may use outside of the US court system or the Department of Justice? A. Application Integrity Policy B. Seizure C. Injunction D. Disgorgement Answer: A Question: 117 The Quality System Regulation (QSR) for medical devices (21CFR 820) requires all of the following except: A. Management to make a commitment to quality B. A Quality Plan that defines how quality will be met C. Management must review the Quality System at least quarterly D. A Quality representative must be identified and documented Answer: C Question: 118 As the sponsor of an approved drug product, you receive information that your distributed product is exhibiting unexpected properties suggesting chemical, physical, or bacteriological change. You are required to report this information as follows: A. Within 7 calendar days to the local FDA district office B. Within 3 working days to the local FDA district office C. In the annual report Visit us at D. Within 15 calendar days to reviewing FDA office Answer: B Question: 119 According to FDA policy, qualified individuals that are non-MDs can conduct clinical trials as long as an individual listed as a co- or sub-investigator has one of the following credentials is except: A. Doctor of Pharmacy (PharmD) B. Medical Doctor (MD) C. Doctor of Dental Science (DDS) D. Doctor of Osteopathic Medicine (DO) Answer: A Question: 120 The following are objectives of a pre-approval inspection except: A. Assess cGMP compliance B. Scientific review of data to assess safety and efficacy C. Collect samples for analysis by FDA D. Verify accuracy of data submitted in an application Answer: A Question: 121 According to GMPs, the following product labels should be rejected except which of the following: A. Labeling and packaging materials that do not meet the approved specifications B. Labeling and packaging materials that remain at the end of a production shift C. Obsolete and outdated labels D. Gang printed labeling that is not differentiated by size, shape or color Answer: B Question: 122 Visit us at Which of the following best describes Advisory Committee meetings? A. Advisory Committee meetings are always open to the public B. Advisory Committee meetings only occur in the product approval stage C. FDA must follow resulting recommendations of Advisory Committee D. Advisory Committee meetings are a way for FDA to consult with outside experts Answer: D Question: 123 An OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks is an example of what type of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: A Question: 124 Your company is developing a product to treat a serious and life threatening disease. A clinically meaningful, well established primary endpoint will be used in the pivotal studies. Which regulatory strategy might you select prior to commencing Phase 3 studies? A. Request Special Protocol Assessment B. Request Fast Track Designation C. Request Priority Review D. Approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses Answer: A Question: 125 our company wants to conduct a small exploratory study for an alternate dosing regimen for an approved drug/approved indication. As a Regulatory Affairs professional, your first advice is: A. The results of the study may potentially be useful to support a label change B. The study must be conducted under an IND Visit us at C. You cannot conduct the study unless you intend to pursue a label change D. Increase the size of the study in order to demonstrate statistical significance Answer: B Question: 126 According to GMP regulations, the quality control unit is responsible for which of the following activities: A. Issuing unique identification to all major manufacturing equipment B. Manufacturing drug products C. Warehousing and distributing drug products D. Approving and rejecting raw materials, components, label, drug products, procedures and specifications Answer: D Question: 127 Written procedures (SOPs) for production and process control deviation must meet all the following criteria except: A. Must exist for production and process controls B. Must assure that the drug products have the identity, strength, quality and purity C. Must be reviewed and approved by the quality control unit D. Must be written by the production function Answer: D Question: 128 Which of the following conditions may be expected to lead to a field recall action? A. Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of Federal Food, Drug & Cosmetic Act B. Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection C. Stock Recovery of a device has not left direct control of manufacturer D. Routine servicing Answer: B Visit us at Question: 129 The FDA wants to develop a new guidance document on electronic submissions. Initially, the best way for FDA to obtain industry input for the preparation of a first draft is to A. Schedule an advisory panel meeting B. Announce a public hearing on the issue C. Conduct talks with a number of trade associations D. Issue a Federal Register notice of intent to promulgate a guidance document Answer: C Question: 130 All of the following are considered General Controls under the FD&C Act except: A. Establishment Registration B. Pre-market Approval Application C. Quality System Regulation D. Device Listing Answer: A Question: 131 For a marketed product, which of the following is not an example of a "prior approval" supplement? A. Manufacturing process change B. Change impacting product sterility C. Add a precaution to label D. Delete specification for drug substance Answer: C Question: 132 Which of the following is an example of a "Changes Being Effected" supplement? A. Add/strengthen a contraindication, warning Visit us at B. Change in specifications to comply with an official compendium C. Editorial change D. Deletion or reduction of an ingredient to affect color Answer: A Question: 133 An FDA Form 1572 Statement of the Investigator should be revised for all of the following except: A. A change in the principal investigator for the study B. A change in sponsor medical monitor for the study C. The addition of a local lab or health care facility to which the study patients make visits D. A change in the IRB or the IRB's name Answer: B Question: 134 A female condom is an example of what class of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: C Question: 135 The complete contents of a PMA are broken down into well-delineated components (or module) and each component is submitted to FDA as soon as the applicant has completed the module, compiling a PMA overtime. Allows a company to file the completed portions or modules of a PMA for an ongoing review by FDA. A. True B. False Answer: B Visit us at Question: 136 Cosmetics 21 CFR parts 700s A. True B. False Answer: A Question: 137 Designation given to a product that is incorrectly labeled (i.e., false or misleading or fails to include information required by law). Other violations may also render a product misbranded (e.g., failure to obtain a 510(k) for a device) A. True B. False Answer: B Question: 138 To clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers and distributors. A. True B. False Answer: A Question: 139 Drug products that contain the same active ingredient(s), are of the same dosage form and route of administration and are identical in strength or concentration. A. True B. False Answer: B Visit us at Question: 140 Administrative Issues and Protection of Human Subjects A. True B. False Answer: B Question: 141 Initial safety studies in humans. May be as few as 10 subjects, often healthy volunteers, includes PK, ADME and dose escalation studies. Usually open label (a clinical trial in which subjects and investigators are aware of the treatment received). A. True B. False Answer: A Question: 142 Comparison of a new device to a legally marketed predicate device; substantial equivalence establishes a device is as safe and as effective as another 510(k) cleared device. A. True B. False Answer: B Question: 143 Good Manufacturing Practice (for drugs) A. True B. False Answer: B Visit us at Question: 144 Drug Master File. Submission to FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. A. True B. False Answer: A Question: 145 In part as a result of the Thalidomide tragedy this amendment mandated the establishment of efficacy as well as safety before a drug could be marketed, required FDA to assess the efficacy of all drugs introduced since 1938, introduced stricter agency control over drug trials (including requirement of patient Informed Consent), transferred prescription drug advertising from FTC to FDA, established GMP requirements for the drug industry and granted FDA greater power to access company production and control records to verify those practices. A. True B. False Answer: B Question: 146 Safety and Efficacy A. True B. False Answer: A Question: 147 submitted to FDA to demonstrate that the medical device to be marketed is safe and effective or "substantially equivalent" to a legally marketed device. 510(k) refers to the section of the FD&C Act authorizing the submission of the premarket notification. FDA processing time is 90 days. Visit us at A. True B. False Answer: A Question: 148 Provides the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or marketing application. A. True B. False Answer: B Question: 149 Institutional Review Boards (IRBs) A. True B. False Answer: B Question: 150 Center for Biologics Evaluation and Research A. True B. False Answer: B Question: 151 Violative device is not likely to cause adverse health consequences. A. True B. False Visit us at