52-61.pdf

Question: 177 You, a regulatory affairs professional, are assessing the information to be submitted in support of a marketing application for a new dosage form for a listed drug. You lack right of reference to one key preclinical report. Which type of application will you prepare for submission? A....

Question: 177 You, a regulatory affairs professional, are assessing the information to be submitted in support of a marketing application for a new dosage form for a listed drug. You lack right of reference to one key preclinical report. Which type of application will you prepare for submission? A. 505 (b) (1) B. 505 (b) (2) C. 505 (j) D. PMA Answer: B Question: 178 The Quality System Regulation for Class III devices applies to the following except: A. Critical component manufacturers B. Operations done by the manufacturer at facilities located in the United States C. Research on investigational devices tested outside of the United States D. Contract Sterilizers Answer: A Question: 179 It is acceptable for FDA forms completed and submitted by the principal investigator to support an IND submission to include the which of following: A. Typed name in the signature block B. Rubber stamped name in the signature block C. Handwritten dates D. Signature of study staff personnel on behalf of the investigator Answer: C Question: 180 According to the QSR, Design Outputs contain the following: Visit us at A. The Device Master Record (DMR) B. The documentation from the last phase of the complete Design Control process C. The test reports that support that the Design Inputs have been met D. All of the packaging and labeling associated with the finished device E. A and D above A. B. Devices or their components B. D. Phase 1 study design changes that do not affect critical safety assessments. C. E. A and D above A The Device Master Record (DMR) D All of the packaging and labeling associated with the finished device D. D. Approving and rejecting raw materials, components, label, drug products, procedures and specifications Answer: C Question: 181 ll 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: B Question: 182 You, a regulatory affairs professional, are in a situation where an administrative or procedural dispute has occurred between the sponsor and the FDA reviewing division. In attempt to resolve the dispute, on what level would you initially try to resolve the dispute? A. Review Division B. Agency Ombudsman C. Office Director D. FDA Office of Regulatory Affairs Answer: A Question: 183 Which of the following products would not be regulated by CDER? Visit us at A. Therapeutic proteins B. Vaccines C. Chemically synthesized small molecules D. Monoclonal antibodies Answer: B Question: 184 Which of the following is a true statement regarding advertising/promotion of prescription drug products? A. All promotional materials must be approved by FDA prior to use B. All promotional materials must be approved by the Federal Trade Commission C. Advertising directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA D. Advertising is not allowed for drugs approved under accelerated approval/Subpart H Answer: D Question: 185 Management should be notified in writing of the GMP Investigations conducted for all of the following except: A. Product Complaints B. Batch Production Record documentation corrections C. Returned Drug Products D. Drug Product Salvaging Answer: B Question: 186 The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported. A. Manufacturers B. Distributors C. Initial importers D. User facilities Visit us at Answer: B Question: 187 A label is defined as that which is affixed to the: A. Carton B. Shrink Wrapper C. Shipping Package D. Immediate Container Answer: A Question: 188 GLP study directors are required to conduct the following activities except: A. Approving the final study reports B. Maintenance of the master schedule C. The protocol is approved and followed D. Experimental data are accurately reported and verified Answer: A Question: 189 A non-powered microsurgical instrument for use in neurological microsurgery procedures is an example of what kind of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: A Question: 190 Visit us at You, a regulatory affairs professional, receive a warning letter from DDMAC pertaining to DTC advertising. The first thing you do is: A. Develop a corrective advertisement B. Write a response letter to DDMAC C. Cease dissemination of violative materials D. Review the marketing application Answer: C Question: 191 Premarket Notification Requirements would apply to a device that is: A. Substantially equivalent to a pre-amendment device B. Intended solely for use by a specific physician C. Not equivalent to currently marketed devices D. Intended for veterinary use Answer: A Question: 192 According to the QSR, Quality Audits must accomplish the following: A. Meet the same requirements of the original GMP B. Evaluate if the Quality System is in compliance with the QSR C. Determine the effectiveness of the Quality System D. Focus on Design Controls and the CAPA system E. B and C above F. A and D above A. E, B and C above B. Evaluate if the Quality System is in compliance with the QSR C. Determine the effectiveness of the Quality System B. D, All of the above C. E, A and D above A, The Device Master Record (DMR) D, All of the packaging and labeling associated with the finished device D. C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA Answer: A Visit us at Question: 193 The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following: A. Finished devices, but not accessories B. Finished devices and components of finished devices C. Finished devices and accessories to finished devices D. Finished devices, components, and accessories to finished devices Answer: C Question: 194 Under the official definition of a "device", all of the following are considered devices except: A. X-ray film B. Sterilizers used for device manufacturing C. Eyeglass lenses and frames D. In vitro diagnostic kit Answer: A Question: 195 Which of the following examples best represents "fair balance"? A. Risks and benefits are presented in comparable prominence, readability B. A reminder ad C. Established name appears next to brand name in type at least 50% of brand name D. Advertising directed to physicians and consumers Answer: A Question: 196 In which situation is an IND not required? A. You intend to conduct a clinical trial with an investigational new drug Visit us at B. You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C. You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D. You intend to conduct a clinical trial using 2 of your approved drugs in a new combination Answer: C Question: 197 With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial? A. Informed consent of trial participants B. IRB approval of the trial C. Financial disclosure by investigators D. Submission of the trial protocol to FDA for approval Answer: D Question: 198 How often should employees receive training in GMPs? A. On an annual basis B. Semi-annually C. Annually D. On a continuing basis Answer: D Question: 199 A male condom is an example of what class of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: B Visit us at Question: 200 Non-prescription sunglasses are an example of what kind of device? A. Class 1 B. Class 2 C. Class 3 D. No way is this a device Answer: A Question: 201 Which of the following examples do not meet the definition of adulteration? A. A bottle of aspirin (for public retail sale) that is not packaged in tamper-resistant packaging B. Batch record was accidentally destroyed C. Incorrect lot number on the label D. A drug recognized in the USP/NF that does not meet all compendium standards Answer: C Question: 202 According to the Federal Food, Drug and Cosmetics (FD&C) Act, a drug is defined as all of the following except: A. Recognized in the US Pharmacopoeia , Homeopathic Pharmacopoeia of the United States, or the National Formulary B. Devices or their components C. Intended for diagnosis, cure, mitigation, treatment or prevent of disease in humans or other animals D. Intended to affect the structure or any function for the body of humans or other animals Answer: B Question: 203 According to the QSR, Design Inputs are best described by the following: Visit us at A. The Operator's Manual and instructions on how to use the device B. The Instructions For Use (IFU) of the device C. Marketing claims and features that are required for the device D. The performance requirements that the product must meet Answer: D Question: 204 Which of the following is typically included in a reminder advertisement? A. Brand and generic names B. Indication(s) C. Dose information D. Statement of efficacy Answer: A Question: 205 ADEs that do not meet 15-day reporting requirements should be reported by the applicant: A. Annually, unless alternate reporting arrangement is required by FDA B. Semi-annually, unless alternate reporting arrangement is required by FDA C. Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA D. Quarterly for 1st year after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA Answer: C Question: 206 Which of the following best represents the Quality Systems Inspection Technique? A. Focus on Manufacturing and Manufacturing Processes B. Focus on QC testing and Product Release C. Focus on Batch Record Review D. Focus on Management Answer: D Visit us at Visit us at