RAC GS Practice Test

1. Pass RAC-GS - Regulatory Affairs Certification (RAC) Global Scope exam in just 24 HOURS! 100% REAL EXAM QUESTIONSANSWERS RAC-GS - Regulatory Affairs Certification(RAC) GlobalScope Buy Complete Questions Answers File from http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html 100% Exam Passing Guarantee & Money BackAssurance SampleQuestions

2. Question No1: The Food and Drug Administration Modernization Act (FDAMA) established two types of formal early collaboration meetings. Which of the following is one of thosemeetings? PDPmeeting AgreementMeeting Pre-IDEmeeting Type Ameeting Answer:B Question No2: A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will form the primary basis of an efficacy claim in an NDA. Which of the following is TRUE? The sponsor should submit the SPA request within 30 days following the start of the trial to expedite FDAfeedback An SPA provides an opportunity to focus on general drug developmentissues The SPA request will be handled as a request for a Type B meeting A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the sameprotocol Answer: D Question No3: Devices that are exempt from premarket notificationare: All Class Idevices Some Class Idevices Most Class I devices and some Class IIdevices All Class I devices and some Class IIdevices Answer: C Question No4: Your company wishes to seek approval of a combination of individually approved anti- hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed combination. Which of the following regulatory pathways is mostapplicable? A. 505(b)(2) B. 510(k)

3. C. 505(b)(1) D. 505(j) Answer: A Question No5: The following applies to autologous chondrocytes expanded in vitro for the repair of cartilage defects: Regulated under Section 351 of the Public Health Service Act and no premarket approval required Regulated under Section 351 of the Public Health Service Act and premarket approval required Regulated under Section 361 of the Public Health Service Act and no premarket approval required Regulated under Section 361 of the Public Health Service Act and premarketapproval required Answer: B Question No6: Which of the following is the best regulatory pathway for drugs containing similar active ingredients as a previously approved drug for a newindication? A. 505(j) ANDA B. 505(b)(1) NDA C. 505(b)(2)NDA D. 505 (d) Substantial Evidence ofEffectiveness Answer: C Question No7: In order to be approved by FDA, a generic drug must be therapeutically equivalent to the branded product with the exceptionof: DosageForm Route ofAdministration InactiveIngredient(s) Labeling Answer:C

4. Question No8: Your company is developing a New Chemical Entity (NCE) drug to treat Glioblastoma multiforme, which is the deadliest and most common form of malignant brain tumor. The compound team has designed a pivotal study protocol with a clinically meaningful and well- established primary endpoint. To increase the likelihood FDA will agree with the study design, which of the following regulatory strategies has to occur prior to initiating the pivotal study? Request Fast Trackdesignation Request priorityreview Request approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life ThreateningIllness Request Special ProtocolAssessment Answer: D Question No9: Which federal law made it illegal for physicians being reimbursed by federally funded programs to prescribe or recommend that the patient use a particular manufacturer's medical products when the doctor receives payment from thatmanufacturer? Medicare and Medicaid Patient Protection Act of1987 Food, Drug, and Cosmetic Act of 1938 (FD&CAct) Food and Drug Administration Modernization Act of 1997(FDAMA) Food and Drug Administration Amendments Act of 2007(FDAAA) Answer: A Question No10: Company Z selected a proprietary name for its new molecular entity, currently in development. The NDA will be submitted in six months. All of the following are Relevant to the proprietary nameEXCEPT: The request for proprietary name approval may be submitted with theNDA. The proprietary name submission package may be Submitted up to one month after NDAsubmission. The request for proprietary name approval may be submitted prior to the NDA. FDA will communicate to the applicant a tentative acceptance or non-acceptance of the proposed proprietary name submitted with the NDA within 90 days of the receipt of the completesubmission. Answer:B

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