RAC (Drugs) Practice Test PDF

14/03/2024, 17:03 View and Edit Coaching Report Assessment Name RAC (Drugs) Practice Test Status Finished User ID 10916440 Percentage Score 60% Date/Time Started Mar 11 2024 11:19:31 Assessment Outcome Fail Date/Time Finished Mar 11 2024 12:14:23 Questions Topic Email RAC Practice Test Results Question wording You will receive your full practice test results after the completion of this test. If you would like a copy of your results delivered via email, please enter your email address below. Please verify your email address is correct before proceeding. Choices Unscored, Scored Answer given [email protected] Correct answer N/A Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A company is developing an unapproved drug-device combination product in which the primary mode of action is the drug. What application type and to which center should the company submit its application for marketing approval? Choices 0 Submita Premarket Application to CDRH, 1 Submitan Investigational New Drug Application , 2 Submita Premarket Notification application to , 3 Submita New Drug Application to CDER Answer given Submit a New Drug Application to CDER Correct answer Submit a New Drug Application to CDER Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A sponsor is planning to initiate a pivotal clinical study for a drug-lead combination product (e.g. prefilled syringe, autoinjector, etc.). For the device constituent of the combination product, what’s the FDA minimum regulatory requirement that must be met prior to introducing the combination product into the clinical study? Choices 0 Meet combination product cGMP requirements accor, 1 Meet the usabilityhuman factors requirement., 2 Meet the design controls requirement according t, 3 Meet the EU MDR General Safety and Performance R Answer given Meet the design controls requirement according to 21 CFR Part 820.30, unless the device constituent is exempt from design controls requirements. Correct answer Meet the design controls requirement according to 21 CFR Part 820.30, unless the device constituent is exempt from design controls requirements. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 1/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is not the sponsor’s responsibility? Choices 0 Designate appropriately qualified medical person, 1 Maintaining records of receipt, use and disposit, 2 Submitting unanticipated adverse event reports t, 3 Update the Investigators Brochure as significant Answer given Designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems. Correct answer Maintaining records of receipt, use and disposition of investigational product. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is false regarding FDA expedited programs? Choices 0 The level of evidence required for Fast Track De, 1 Breakthrough Therapy Designation and RMAT Design, 2 RMAT Designation should be requested with the IN, 3 Fast Track Designation, Breakthrough Therapy Des Answer given The level of evidence required for Fast Track Designation is less than for Breakthrough Therapy Designation. Correct answer Breakthrough Therapy Designation and RMAT Designation require evidence to indicate that the drug may offer a substantial improvement relative to available therapies. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Your company is developing an autologous cellular therapy product. FDA informed the company its product will be regulated as an HCT/P (Human Cells, Tissues and Cellular and Tissue-Based Product). Based on this information, with which of the following regulatory requirements will your company need to be compliant when manufacturing the product? Choices 0 21 CFR 210 211 (CGMP requirements for pharmaceu, 1 21 CFR 2171 and 21 CFR 820, 2 All Subparts of 21 CFR 1271 except Subpart C (Do, 3 All Subparts of 21 CFR 1271 Answer given All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) Correct answer All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following labeling elements is NOT required for all over-the-counter drugs in the U.S.? Choices 0 Name and place of business of manufacturer, pack, 1 Net quantity of contents, 2 Statement of ingredients, 3 Pregnancybreast-feeding warning Answer given Pregnancy/breast-feeding warning Correct answer Pregnancy/breast-feeding warning https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 2/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following statements about human factors (HF) validation studies are not true? Choices 0 FDA expects that for most drug-lead combination , 1 A HF actual-use validation study may be needed w, 2 FDA expects that a HF simulated-use or actual-us, 3 Tasks to be performed in the HF simulated-use va Answer given A HF actual-use validation study may be needed when it is difficult to simulate the conditions of use, physical characteristics of the product, or environment of use. Correct answer FDA expects that a HF simulated-use or actual-use validation study must be performed to support marketing authorization of a drug-led combination product (in other words, a risk-based rationale to waive the HF validation study is not acceptable). Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Blood Center ABC has just opened in a Midwestern state. It plans to manufacture blood and blood products from volunteer blood donors and offer these products for sale to local dialysis clinics and hospitals in other states. Blood Center ABC must: Choices 0 Register with FDA within five days after beginni, 1 Wait to distribute any blood products until an F, 2 Submit a BLA to FDA prior to distributing any bl, 3 Submit a label supplement to FDA prior to distri Answer given Submit a BLA to FDA prior to distributing any blood products in interstate commerce Correct answer Register with FDA within five days after beginning operations and provide a current list of all products manufactured, prepared and processed that are in commercial distribution Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is TRUE regarding expedited programs for regenerative medicine therapy products? Choices 0 Information that supports more than one expedite, 1 CBER grants Fast Track Designation only on the b, 2 For Breakthrough Therapy Designation, preclinica, 3 Advantages of the RMAT Designation include all o Answer given Information that supports more than one expedited program designation may be combined into a single submission. Correct answer Advantages of the RMAT Designation include all of the benefits of Fast Track Designation and Breakthrough Therapy Designation. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is a required record when a prescription drug is sold by a manufacturer to a chain pharmacy’s warehouse? Choices 0 Certificate of analysis, 1 Product and lot information, 2 History of product ownership changes, 3 Wholesale acquisition cost Answer given Product and lot information Correct answer Product and lot information https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 3/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is false regarding meeting minutes for formal meetings relating to biological products regulated by CBER? Choices 0 The FDA will issue official meeting minutes to t, 1 The FDA meeting minutes are not intended to repr, 2 If it is necessary to revise the original FDA me, 3 For input on additional issues not addressed at Answer given For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Correct answer For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording On Monday, commercial stability batch testing for an approved drug produced out-of-specification results. No assignable cause had been identified as of Wednesday. What is the best action for the regulatory professional to take? Choices 0 Issuea Field Alert, 1 Initiateretesting, 2 Initiateresampling, 3 Issuean Investigative Protocol Answer given Issue an Investigative Protocol Correct answer Issue a Field Alert Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording For a biological drug product regulated by CBER, FDA intends to hold a Type C meeting within how many days after receipt of a sponsor meeting request? Choices 0 30, 1 60, 2 70, 3 75 Answer given 75 Correct answer 75 Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of biological products? Choices 0 Meetings may be electronically recorded., 1 The questions submitted to CBER within a single , 2 The meeting package should generally not contain, 3 The meeting requester or other meeting participa Answer given Meetings may be electronically recorded. Correct answer Meetings may be electronically recorded. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following changes to an approved NDA can be implemented prior to FDA approval? Choices 0 Eliminationof unnecessary in-process controls, 1 Extensionof the expiration date based on shelf, 2 Implementationof modifications that, if delaye, 3 Useof a new GMP facility to manufacture the dr Answer given Elimination of unnecessary in-process controls Correct answer Extension of the expiration date based on shelf life obtained from the stability protocol in the approved application https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 4/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording What statements would NOT be correct about an Authorized Generic Drug? Choices 0 It is a copy of a brand-name drug that is develo, 1 It is the same as the brand name drug in active , 2 It is the same as the brand-name drug but does n, 3 It is not listed in the Orange Book. Answer given It is a copy of a brand-name drug that is developed and made by a company other than the company that makes the brand-name drug. Correct answer It is the same as the brand name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Your company is planning to place a generic, non-biologic product on the market. The original product manufacturer’s data exclusivity period is over. As a regulatory professional, how will you advise your company to obtain a faster Marketing Authorisation? Choices 0 Atthe outset, to commission a top rated clinic, 1 Toconduct bioavailability and bioequivalence s, 2 Nofresh documentation is required for a Market, 3 Toconduct all the studies and generate the req Answer given To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer’s file for the rest of the documentation Correct answer To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer’s file for the rest of the documentation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A clinical trial for a medicinal product was conducted in several European countries and has been finalized. What is the MOST appropriate next regulatory step? Choices 0 Filea declaration on the end of the clinical t, 1 Informthe EMA that the study is finalized and , 2 Preparethe final clinical study report for the, 3 Submitscientific advice to the CA to receive f Answer given File a declaration on the end of the clinical trial to the CA and ethics committees of the participating countries Correct answer File a declaration on the end of the clinical trial to the CA and ethics committees of the participating countries Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording What advice should the regulatory professional give a clinical trial sponsor on the content required for the label on a study drug? Choices 0 Forsites in the EU, the labeling must specify , 1 Arandomisation code on the label is necessary , 2 Eitherthe sponsor, the Clinical Research Organ, 3 Thestatement “Keep out of reach of children” i Answer given Either the sponsor, the Clinical Research Organization (CRO) or both may appear on the label so both entities can simultaneously report any unexpected serious adverse events Correct answer For sites in the EU, the labeling must specify the period of use for the product https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 5/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording During what period of the MRP should an individual within the applicant company always be available to resolve any issues that may arise? Choices 0 Five-dayperiod immediately following the close, 1 Ten-dayperiod for the preparation of the respo, 2 Ninety-dayperiod for the reference member stat, 3 Ninety-dayperiod for approval by the concerned Answer given Ninety-day period for the reference member state to update the assessment report Correct answer Ninety-day period for approval by the concerned member states Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A clinical investigator would like to use an investigational medicinal product to treat a gravely ill patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the clinical investigator, the product would be the best option for that patient. What action is MOST appropriate for the clinical investigator to take? Choices 0 Askthe trial sponsor to obtain CA approval for, 1 Notifythe trial sponsor of the deviation to th, 2 Obtainapproval from the CA for compassionate u, 3 Treatthis particular patient with the product, Answer given Obtain approval from the CA for compassionate use of the product for this particular patient Correct answer Obtain approval from the CA for compassionate use of the product for this particular patient Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A manufacturer is sponsoring a pharmaceutical clinical trial. Before starting the trial, the clinical investigator MUST first obtain which of the following? Choices 0 Publicationcopyright statements, 1 Approvalfrom the ethics committee, 2 Signedinformed consent forms, 3 AppropriateICH forms Answer given Approval from the ethics committee Correct answer Approval from the ethics committee Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A biotechnology company is developing a follow-on biologic it claims is similar to an authorised biologic medicinal product and already available on the market. What should the regulatory professional submit with the Marketing Authorisation Application dossier? Choices 0 Abridgedquality dossier including only compara, 1 Fullquality dossier, 2 Fullquality dossier supplemented by the demons, 3 Noneed to include a quality dossier Answer given Abridged quality dossier including only comparability data demonstrating the follow-on biologic is biosimilar to the reference product Correct answer Full quality dossier supplemented by the demonstration of comparability https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 6/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Clinical studies for an Investigational Medicinal Product are nearing the end of Phase 2, and the development team is actively planning Phase 3. The team is interested in seeking feedback from the Committee for Medicinal Products for Human Use (CHMP) on the proposed Phase 3 study design. As the regulatory professional on this team, what information should you offer related to Scientific Advice? Choices 0 ScientificAdvice is legally binding on the app, 1 ScientificAdvice is both retrospective and pro, 2 Itis always appropriate to request Scientific , 3 IfScientific Advice is not followed, the reaso Answer given If Scientific Advice is not followed, the reasons will need to be discussed in the subsequent submission documents Correct answer If Scientific Advice is not followed, the reasons will need to be discussed in the subsequent submission documents Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A firm can assure effective process validation for a new medicinal product best by conducting which of the following types of validation? Choices 0 Prospective, 1 Concurrent, 2 Retrospective, 3 Cleaning Answer given Prospective Correct answer Prospective Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording As per EMA Variation Guideline, when the national competent authorities or the European Medicines Agency needs to be notified of the change (submitted) immediately upon implementation, the type of variation is: Choices 0 Type 1A, 1 Type 1Ain, 2 Type 1B, 3 Type II Answer given Type 1A Correct answer Type 1Ain Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording After several years of successful marketing of a medicinal product for human use, a company wants to authorize a new therapeutic indication for the product. What is the MOST appropriate regulatory submission route? Choices 0 TypeIA variation, 1 TypeIB variation, 2 TypeII variation, 3 Extensionapplication Answer given Type II variation Correct answer Type II variation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What could form part of the procedures for a non-interventional imposed PASS (Post Authorization Safety Study)? Choices 0 After study commencement, the MAH must submit an, 1 Final Assessment by Pharmacovigilance Risk Asses, 2 Upon study completion, a final study report with, 3 All of the above. Answer given All of the above. Correct answer All of the above. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 7/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording A manufacturer of an advanced therapy medicinal product verifies that its equipment used to manufacture the medicinal product adheres to user specifications and GMP requirements. These steps would NOT include which of the following: Choices 0 Installation Qualification (IQ), 1 Operational Qualification (OQ), 2 Process Qualification (PQ), 3 Performance Qualification (PQ) Answer given Installation Qualification (IQ) Correct answer Process Qualification (PQ) Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What regulatory information is included in the Official Journal of the European Union? Choices 0 Draftguidelines relevant to pharmaceuticals, 1 Noticesof product recalls within the EU, 2 Proposedand final EU legislation, 3 Summariesof final EU legislation in every EU l Answer given Summaries of final EU legislation in every EU language Correct answer Proposed and final EU legislation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording Which of the following statements regarding the duties of the Qualified Person (QP) responsible for batch release is correct? Choices 0 TheQP is responsible for confirming the qualit, 1 TheQP release is necessary for approved human , 2 TheQP release does not apply for veterinary me, 3 Asigned contract agreement by the QP can waive Answer given The QP is responsible for confirming the quality of medicinal products in accordance with the requirements of the Marketing Authorisation Correct answer The QP is responsible for confirming the quality of medicinal products in accordance with the requirements of the Marketing Authorisation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What is the least likely action OPDP will take in response to this promotional communication? Choices 0 OPDP will consider whether the promotional mater, 1 OPDP will consider the REMS and boxed warnings i, 2 OPDP will consider whether the promotional claim, 3 OPDP will take no action as their role is purely Answer given OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. Correct answer OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 8/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A company is developing a new line of products in an area that is new to the company. What is the BEST approach? Choices 0 Askthe trade association representative to pro, 1 Obtaincompetitor research and provide the info, 2 Obtainregulatory documents and history and pro, 3 Summarizeregulatory documents and history and Answer given Summarize regulatory documents and history and provide the information to the management team Correct answer Summarize regulatory documents and history and provide the information to the management team Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following is MOST appropriate for the purpose of lot release of biologics? Choices 0 Inventorycontrol, 1 Safetyassurance, 2 Efficacyconfirmation, 3 Qualityverification Answer given Quality verification Correct answer Quality verification Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A sponsor is investigating the impact of a manufacturing process change to its cellular therapy product. After evaluating the relevant quality attributes, for which outcome can the pre-change product and post-change product be considered comparable? Choices 0 The pre-change product and post-change product a, 1 The pre-change product and post-change product a, 2 The pre-change product and post-change product a, 3 The pre-change product and post-change product a Answer given The pre-change product and post-change product are highly similar. Some differences have been noted in the quality attributes of the products. No adverse impact on safety or efficacy of the product is anticipated. Correct answer The pre-change product and post-change product are highly similar. Some differences have been noted in the quality attributes of the products. No adverse impact on safety or efficacy of the product is anticipated. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording In what module of the CTD is information on the quality of a medicinal product noted? Choices 0 1, 1 2, 2 4, 3 5 Answer given 2 Correct answer 2 https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b195… 9/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following is BEST identified as a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality? Choices 0 Designspace, 1 Manufacturingcontrols, 2 Operatingranges, 3 Specification Answer given Manufacturing controls Correct answer Design space Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following documents outlines whether a serious adverse event occurring during a clinical trial is considered expected or unexpected? Choices 0 Clinicaltrial application, 1 Clinicaltrial report, 2 Ethicscommittee document, 3 IB Answer given Clinical trial application Correct answer IB Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover? Choices 0 Potentialclinical sites for the Phase III clin, 1 Regulatoryrequirements for labeling and packag, 2 Capacityof the manufacturing facilities to ful, 3 Previousactions taken by regulatory authoritie Answer given Previous actions taken by regulatory authorities on similar products Correct answer Previous actions taken by regulatory authorities on similar products Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A company is publishing an application to initiate the first clinical trial involving a new investigational drug and discovers that some stability results are not available. Which of the following individuals should the publisher contact FIRST to inquire about the missing data? Choices 0 Clinicalaffairs managerdirector, 1 Regulatoryaffairs managerdirector, 2 QCmanagerdirector, 3 QAmanagerdirector Answer given Clinical affairs manager/director Correct answer Regulatory affairs manager/director Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A company has a product on the market in Country X. To ensure successful launch of the product in Country Y, which of the following resources should be examined FIRST? Choices 0 CountryXs reports of adverse events, 1 CountryXs regulatory history of the product, 2 CountryYs manufacturer association, 3 CountryYs regulatory agency website Answer given Country Y's regulatory agency website Correct answer Country Y's regulatory agency website https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b19… 10/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication? Choices 0 ProductX is a guaranteed cure for arthritis., 1 ProductX is effective for the treatment of art, 2 ProductX is safe for arthritis and without sid, 3 ProductX is effective in all patients with art Answer given "Product X is effective for the treatment of arthritis." Correct answer "Product X is effective for the treatment of arthritis." Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following statements about biosimilars is NOT correct? Choices 0 Biosimilars cannot be substituted for reference , 1 Biosimilars are considered as generic pharmaceut, 2 Biosimilars cannot demonstrate superiority in co, 3 In some countriesregions, biosimilars may be app Answer given Biosimilars are considered as generic pharmaceuticals and use the same marketing review procedures Correct answer Biosimilars are considered as generic pharmaceuticals and use the same marketing review procedures Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording For a biological drug product regulated by CBER, FDA intends to hold a Type C meeting within how many days after receipt of a sponsor meeting request? Choices 0 30, 1 60, 2 70, 3 75 Answer given 75 Correct answer 75 Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording What is the BEST approach to ensure that raw materials, services, and subcontractors at the level of the vendors comply with GMP requirements? Choices 0 Askthe vendor to take responsibility, 1 Documentand perform audits, 2 Requestan inspection from a regulatory authori, 3 Requestdocumentation from the sub-contractor Answer given Document and perform audits Correct answer Document and perform audits Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following claims would classify an apple as a drug? Choices 0 Itwill make you look younger., 1 Itwill satisfy hunger., 2 Itwill whiten teeth., 3 Itwill prevent colds. Answer given "It will prevent colds." Correct answer "It will prevent colds." https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b19… 11/13 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following terms is defined as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously? Choices 0 Index, 1 Sign, 2 Signal, 3 Symptom Answer given Sign Correct answer Signal Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A regulatory professional is preparing a clinical trial application for the company's new product. During the review of the clinical protocol, operational difficulties in the execution of the protocol were discovered. What is the BEST action for the regulatory professional to take? Choices 0 Askfor a consultation with the regulatory agen, 1 Askfor pre-inspection from the regulatory agen, 2 Consultthe advisory committee of the regulator, 3 Consultthe IRB Answer given Consult the IRB Correct answer Ask for a consultation with the regulatory agency Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of biological products? Choices 0 Meetings may be electronically recorded., 1 The questions submitted to CBER within a single , 2 The meeting package should generally not contain, 3 The meeting requester or other meeting participa Answer given Meetings may be electronically recorded. Correct answer Meetings may be electronically recorded. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation. What should be done. What action should the company take FIRST? Choices 0 Initiatetesting immediately to ensure complian, 1 Consultwith colleagues about the request, 2 Contactthe regulatory authority that issued th, 3 Senda letter back to the regulatory authority Answer given Initiate testing immediately to ensure compliance Correct answer Contact the regulatory authority that issued this request and discuss the requirement Topics Topic description EU Based Questions: Domain I and II Topic Detail Score % 67% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b19… 12/13 14/03/2024, 17:03 View and Edit EU Based Questions: Domain III and IV Topic Detail Score % 57% Global Based Questions: Domain I and II Topic Detail Score % 67% Global Based Questions: Domain III and IV Topic Detail Score % 67% US Based Questions: Domain I and II Topic Detail Score % 44% US Based Questions: Domain III and IV Topic Detail Score % 57% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=2030055406&TemplateID=2&da=1&digest=aebac83186b19… 13/13

RAC (Drugs) Practice Test PDF

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