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 46% Date/Time Started Mar 14 2024 10:58:11 Assessment Outcome Fail Date/Time Finished Mar 14 2024 11:38:35 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 Which of the following would require a Type A meeting with the US FDA? Choices 0 Certain End-of-Phase 1 meetings, 1 Dispute resolution, 2 End-of-Phase 2 meetings, 3 Pre-NDA meetings Answer given Dispute resolution Correct answer Dispute resolution Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine a blood donor’s hematocrit prior to donation. The firm should address the 510(k) submission to: Choices 0 CDER, 1 CBER, 2 CDRH, 3 OCP Answer given CDER Correct answer CBER https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 1/14 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording While a company's NDA submission is under review at FDA, the US Pharmacopeial Convention issues a revised monograph involving a minor change to the company's product. Which of the following actions is the regulatory professional's MOST appropriate response? Choices 0 Conducttesting and submit the change as an ame, 1 Obtainapproval for submission and submit the c, 2 Petitionthe FDA for a stay of action and recon, 3 Takeno action and leave the submission at the Answer given Conduct testing and submit the change as an amendment Correct answer Obtain approval for submission and submit the change in the next annual report 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 Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Part way through an early-stage exploratory IND for an oncology drug trial, the Sponsor requests your regulatory advice on amending the existing Protocol to include a new subset of disease and to add a new Investigator. What scenario below BEST captures the advice you should give? Choices 0 The sponsor should notify FDA within 30 days tha, 1 The sponsor should notify FDA of the new investi, 2 No reporting to FDA or IRB is required as the am, 3 The sponsor should notify FDA of the new investi Answer given The sponsor should notify FDA of the new investigator within 30 days of the investigator being added, report to FDA the addition of the disease subset by way of an amendment to the Protocol and obtain IRB approval. Correct answer No reporting to FDA or IRB is required as the amendments to the Protocol are both considered insignificant to safety in an early-stage trial. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is false regarding orphan drug designation in the US? Choices 0 FDA encourages sponsors to request designations , 1 If a sponsor requests designation for an “orphan, 2 In a designation request for a disease or condit, 3 Prior to submission of a marketing application, Answer given If a sponsor requests designation for an “orphan subset”, it must demonstrate that, due to a property or properties of the drug, the remaining persons with the disease or condition would not be appropriate candidates for use of the drug. Correct answer FDA encourages sponsors to request designations for pediatric subpopulations, which are critical for stimulating the study of drugs in pediatric populations. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 2/14 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 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 Fast Track Designation, Breakthrough Therapy Designation, and RMAT Designation may be rescinded later in product development. 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 Which of the following statements about biosimilars is NOT correct? Choices 0 Biosimilars cannot not be substituted for innova, 1 Biosimilars are considered to be similar to gene, 2 Biological medicine developed to be similar to a, 3 In some countriesregions, biosimilars may be app Answer given Biosimilars are considered to be similar to generic pharmaceuticals and follow the same market review and approval process as generics. Correct answer Biosimilars are considered to be similar to generic pharmaceuticals and follow the same market review and approval process as generics. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Investigational combination products that include a device constituent part are subject to which provision of 21 CFR part 820? Choices 0 Management responsibility (21 CFR 820.20) and Pu, 1 Design Controls (21 CFR 820.30) unless the devic, 2 Corrective and preventive action (21 CFR 820.100, 3 All of the above. Answer given All of the above. Correct answer Design Controls (21 CFR 820.30) unless the device constituent part is exempt from design controls. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following changes can be submitted without an updated batch record for a modified-release product? Choices 0 Componentchange: deletion of colorflavor, 1 Equipmentchange: alternate equipmentsame desig, 2 Processchange: adjustment of equipment beyond , 3 Sitechange: same contiguous campus Answer given Equipment change\: alternate equipment/same design and principle Correct answer Component change: deletion of color/flavor https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 3/14 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 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\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following would FDA consider to be obstructing an inspection? Choices 0 Scheduling an inspection at a date later than re, 1 A facility does not provide an FDA investigator , 2 The facility fails to produce requested records , 3 A facility does not allow the investigator to en Answer given A facility does not allow the investigator to enter the facility for an unannounced inspection, because certain staff members are not immediately available. Correct answer The facility fails to produce requested records in a timely manner, without a reasonable explanation. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording A regulatory professional receives a lengthy letter for a BLA indicating nonapproval. Which of the following actions will restart the review clock? Choices 0 Initiatingdispute resolution procedures, 1 Requestinga rolling review, 2 Submittingthe data as available, 3 Submittingthe complete response Answer given Submitting the complete response Correct answer Submitting the complete response Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording The supplier of a resin used in a container of a marketed drug product is discontinuing production, and the current supply will be exhausted in six months. A different resin has been identified as a replacement. Which of the following mechanisms should the regulatory professional recommend to maintain compliance? Choices 0 Annualreport, 1 CBE, 2 Fieldreport, 3 Post-approvalstudies Answer given Annual report Correct answer Post-approval studies https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 4/14 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 would NOT be a consequence of this change of FDA policy? Choices 0 FDA will no longer exercise enforcement discreti, 1 FDA will comment, if requested, on its complianc, 2 All establishments that manufacture HCTPs regula, 3 The unapproved product may not be administered a Answer given All establishments that manufacture HCT/Ps regulated as drugs or biological products will need an approved biologics license application (BLA) or an investigational new drug application (IND) in effect. Correct answer FDA will comment, if requested, on its compliance or enforcement approach in light of this policy change. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Which of the following are applicable to the Development Safety Update Report (DSUR)? Question wording I. The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed. II. DSUR is used to present safety information collected for an investigational drug only. III. DSUR is required to be submitted every 3 months. IV. The Development International Birth Date (DIBD) is used to determine the start of the annual period for the DSUR. Choices 0 I and IV, 1 II, 2 III and IV, 3 II and III Answer given I and IV Correct answer I and IV 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 regulatory professional is requested to assist on a submission strategy for a non-innovative drug authorized in one member state. What is the BEST strategy for the extension of the license in other member states? Choices 0 Usethe Centralized Procedure, 1 Usethe MRP, 2 Requesta CPP, 3 Applyto each member state in turn Answer given Use the MRP Correct answer Use the MRP https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 5/14 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Which of the following statements regarding European scientific guidelines is CORRECT? Choices 0 Thestandards do not have legal force, 1 Thestandards have full legal force, 2 Thestandards are harmonized upon issuance, 3 Thestandards are harmonized when the CEN recei Answer given The standards are harmonized upon issuance Correct answer The standards do not have legal force Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant? Choices 0 30, 1 70, 2 90, 3 120 Answer given 30 Correct answer 120 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 approval by the concerned member states 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 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 01: Domain I and II Question wording The current consistent adverse drug reaction terms used for product labeling originate from which of the following? Choices 0 WHOAdverse Reactions Terminology, 1 MedicalDictionary for Regulatory Activities, 2 CodingSymbols for a Thesaurus of Adverse React, 3 Councilfor International Organizations of Medi Answer given WHO Adverse Reactions Terminology Correct answer Medical Dictionary for Regulatory Activities https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 6/14 14/03/2024, 17:03 View and Edit 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 Prepare the final clinical study report for the CA and complete the scientific publications for the product 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 According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of the following EXCEPT: Choices 0 APQS can be certified through the ICH Q10 Cert, 1 Manufacturingprocess robustness and continuou, 2 APQS reduces the risk of product failure and i, 3 Providesan opportunity to increase understandi Answer given Provides an opportunity to increase understanding between industry and regulators and more optimal use of industry and regulator resources Correct answer A PQS can be certified through the ICH Q10 Certification Programme, reducing the frequency of inspections Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording The only changes parallel distributors may introduce to the packaging of a centrally authorised medicinal product are: Choices 0 Useof different language versions of labelling, 1 Indicationsfor use, 2 Directionsfor use, 3 Possibleside effects Answer given Use of different language versions of labelling and package leaflet Correct answer Use of different language versions of labelling and package leaflet Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording A variation for a complex manufacturing change should include which of the following? Choices 0 Astatement and CV from an independent pharmace, 1 Anexpert statement and CV from a quality exper, 2 Anexpert statement and CV from a clinical expe, 3 Anexpert statement from the site quality head Answer given An expert statement and CV from a quality expert Correct answer An expert statement and CV from a quality expert https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 7/14 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording Your company has received a Warning Letter from the FDA that your marketed drug product has been found to contain ingredients, which make it adulterated, and it has been linked to hundreds of reports of minor AEs. At the same time a related product has been reported in the press as involving a legal claim by a group of children whose mothers took the medication during pregnancy many years ago. You have successfully marketed this drug for over 20 years without incident. As a regulatory specialist what is your top priority to minimize your company’s legal liability? Choices 0 Gather all pertinent information for a risk-asse, 1 Respond to the FDA WL immediately., 2 Gather all pertinent information and use your 25, 3 Respond without delay to the press reports denyi Answer given Gather all pertinent information and use your 25-year regulatory knowledge and expertise to formulate an action and mitigation plan. Correct answer Gather all pertinent information for a risk-assessment and recommend to the Senior Leadership Team that preliminary legal advice is obtained without delay. 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 Performance Qualification (PQ) Correct answer Process Qualification (PQ) 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 Your company is planning to have a new drug product registered with EMA, and you have been asked to seek scientific advice. In chronological order, what are the events taken place during the planning phase with preparatory meeting? Choices 0 EMA forwards the list of comments on the briefin, 1 EMA appoints the representative for the meeting, 2 Applicant revises the briefing document and incl, 3 Applicant submits an application including a dra Answer given Applicant submits an application including a draft briefing document to the EMA Secretariat Correct answer EMA appoints the representative for the meeting https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 8/14 14/03/2024, 17:03 View and Edit 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. 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 In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use? Choices 0 Productstability, 1 Productregistration, 2 Productformulation, 3 Productrequirements Answer given Product stability Correct answer Product stability Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer. What is the MOST appropriate approach that Company X should take to acquire more information about Company Y? Choices 0 Enterinto an agreement with Company Y to perfo, 1 Recruita professional to gather confidential i, 2 Requestthe needed information from the Board o, 3 Performa thorough library search to gather det Answer given Enter into an agreement with Company Y to perform due diligence. Correct answer Enter into an agreement with Company Y to perform due diligence. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording What is the BEST source for determining the format of an MAA intended for submission to an HA? Choices 0 GMP, 1 LocalHA guidelines, 2 ICH, 3 WHO Answer given Local HA guidelines Correct answer Local HA guidelines https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f3… 9/14 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 A company is developing a new chemical entity. As part of the preclinical investigations, which of the following battery of toxicity tests cannot be waived and MUST be completed? Choices 0 Genotoxicity, 1 Carcinogenicity, 2 Localtolerance, 3 Reproductivetoxicity Answer given Genotoxicity Correct answer Genotoxicity Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which term does NOT describe the same concept as the others? Choices 0 Biosimilars, 1 Follow-onprotein products, 2 Monoclonalantibody, 3 Subsequententry biologics Answer given Biosimilars Correct answer Monoclonal antibody Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs? Choices 0 Formalmortality and morbidity outcomes, 1 Highsystolic and diastolic blood pressures, 2 Organdamage secondary to hypertension, 3 Strokeand cardiovascular events Answer given Formal mortality and morbidity outcomes Correct answer High systolic and diastolic blood pressures https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f… 10/14 14/03/2024, 17:03 Topic View and Edit RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II The safety database for an anti-hypertensive drug consists of the following: Question wording 461 patients exposed for threemonths 343 patients exposed for sixmonths 112 patients exposed for ninemonths 74 patients exposed for 12months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met? Choices 0 100patients for 12 months, 1 200patients for nine months, 2 500patients for three months, 3 3.000total patient exposures Answer given 3.000 total patient exposures Correct answer 100 patients for 12 months Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Dextromethorphan, an over-the-counter cough suppressant, has been subject to WHO discussions about scheduling as a controlled substance due to its psychoactive effects and potential for severe psychological dependence. Which of the below would you recommend as an argument against scheduling? Choices 0 There are no alternatives available., 1 It is widely used., 2 The abuse problem isn’t significant from a publi, 3 Strategies other than scheduling would preserve Answer given Strategies other than scheduling would preserve access while reducing abuse Correct answer Strategies other than scheduling would preserve access while reducing abuse 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 Consult with colleagues about the request Correct answer Contact the regulatory authority that issued this request and discuss the requirement https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f… 11/14 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Your company has received a Warning Letter from the FDA that your marketed drug product has been found to contain ingredients, which make it adulterated, and it has been linked to hundreds of reports of minor AEs. At the same time a related product has been reported in the press as involving a legal claim by a group of children whose mothers took the medication during pregnancy many years ago. You have successfully marketed this drug for over 20 years without incident. As a regulatory specialist what is your top priority to minimize your company’s legal liability? Choices 0 Gather all pertinent information for a risk-asse, 1 Respond to the FDA WL immediately., 2 Gather all pertinent information and use your 25, 3 Respond without delay to the press reports denyi Answer given Gather all pertinent information and use your 25-year regulatory knowledge and expertise to formulate an action and mitigation plan. Correct answer Gather all pertinent information for a risk-assessment and recommend to the Senior Leadership Team that preliminary legal advice is obtained without delay. 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 The sales department consults the regulatory professional regarding plans to use the same sales materials in all countries. Which indication would be acceptable to present in the sales materials? Choices 0 Indication1, 1 Indication2, 2 Indication3, 3 Noindications Answer given No indications Correct answer No indications 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. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f… 12/14 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A specification deviation occurred on seven batches of a pharmaceutical product that could lead to a product recall. In which of the following activities is the regulatory professional MOST closely involved? Choices 0 Developinga recall strategy, 1 Establishingthe causes of the deviation, 2 Sendinga recall letter to the communication ch, 3 Writingnew SOP related to product specificatio Answer given Sending a recall letter to the communication channels Correct answer Developing a recall strategy Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording In its Guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, issued in November 2017 and updated in July 2020, FDA announced a compliance and enforcement discretion policy to give manufacturers time to determine if they need to submit an IND or marketing application. This policy ended in May 2021. Choices 0 FDA will no longer exercise enforcement discreti, 1 FDA will comment, if requested, on its complianc, 2 All establishments that manufacture HCTPs regula, 3 The unapproved product may not be administered a Answer given All establishments that manufacture HCT/Ps regulated as drugs or biological products will need an approved biologics license application (BLA) or an investigational new drug application (IND) in effect. Correct answer FDA will comment, if requested, on its compliance or enforcement approach in light of this policy change. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A drug that has currently accepted medical use, and has limited potential for abuse, physical or psychological dependence, would likely be placed in which controlled substance schedule? Choices 0 Schedule II, 1 Schedule III, 2 Schedule IV, 3 Schedule V Answer given Schedule II Correct answer Schedule IV Topics Topic description EU Based Questions: Domain I and II Topic Detail Score % 44% EU Based Questions: Domain III and IV Topic Detail Score % 43% Global Based Questions: Domain I and II Topic Detail Score % 67% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f… 13/14 14/03/2024, 17:03 View and Edit Global Based Questions: Domain III and IV Topic Detail Score % 44% US Based Questions: Domain I and II Topic Detail Score % 33% US Based Questions: Domain III and IV Topic Detail Score % 43% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=210158096&TemplateID=2&da=1&digest=6d70fe22beb54f… 14/14

RAC (Drugs) Practice Test PDF

Document Details

Tags

Related

Summary

Full Transcript

Upgrade to continue