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The Regulatory Affairs Certification (RAC) is a professional certification. The primary purpose of a professional certification program is to provide an independent
assessment of the knowledge, skills and/or competencies required for competent performance of a professional role.
What is RAC?
Content by RAPS.org
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Question No 1:
An orphan drug product means a product intended for use in a rare disease or condition as defined in FD&C Act Section 526. According to regulations, what constitutes arare disease or condition?
A. A disease or condition which affects fewer than 200,000 people in the USB. A disease or condition which affects fewer than 2% of the population in the USC. A disease or condition identified as rare by the American Medical Association.D. A disease or condition for which the mode of action has not been determined.
Answer: A
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Question No 2:
While reviewing product complaint files for MDR reportability, you noticed a complaint regarding a common failure mode of an implantable screw. There was no patient involvement and no adverse consequences were reported in the complaint. Your firm has initiated a Class I recall for this implantable screw due to safety issues associatedwith this failure mode. As a regulatory professional your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 daysB. A review of the complaint history is needed to see whether such failure mode will likely
cause or contribute to death or serious injuryC. No MDR is needed as there is no patient involvement and no adverse consequences were reportedD. No MDR is needed but you will file this complaint in the recall file
Answer: Ahttps://www.certs4you.com/raps/rac-us-dumps.html
Question No 3:
In the original application for drug "X," your company submitted a comparability protocol outlining a series of proposed, repetitive container closure system changes, the tests and studies that would be used to evaluate the changes, and the acceptance criteria that would be met. The application has since been approveSubsequently, thecomparability test results did not meet some of the predefined acceptance criteriWhat regulatory option does your company have in this situation?
A. Your company may implement the change(s), but an explanation as to why some of the acceptance criteria were not met must be included within the next Annual Report
B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness
C. Your company may still pursue the change(s) and should submit a CBE-30 that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness
D. There is no further regulatory option; the proposed change(s) cannot be implemented since the predefined acceptance criteria were not met.
Answer: Bhttps://www.certs4you.com/raps/rac-us-dumps.html
Question No 4:
The following biological products are regulated by CBER EXCEPT:
A. Immunizing toxoidsB. Monoclonal antibodies for in vitro useC. Monoclonal antibodies for in vivo useD. Infusion of animal sourced cells into a human
Answer: A
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Question No 5:
A medical device may be exported under Section 801(e) of the FD&C Act and shall not be deemed to be adulterated or misbranded under the act if all of the following applyfor the device EXCEPT:
A. It is in accordance with the specifications of the foreign purchaserB. It is not in conflict with the laws of the country to which it is intended for exportC. It is 510(k) cleared or PMA approvedD. It is labeled on the outside of the shipping package that it is "intended for export only"
Answer: C
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Question No 6:
The Food and Drug Administration Amendments Act of 2007 (FDAAA) established all of the following EXCEPT:
A. Expanded FDA authority for postmarket safety of drugs.B. Reauthorization of prescription drug and medical device user fees.C. Incentives to medical device manufacturers to create devices for children.D. Voluntary registration of clinical trials in FDA database.
Answer: D
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Question No 7:
Senior management at your company asked you to develop a justification for Fast Track status for an investigational new cancer drug. Which of the following would NOT bean appropriate justification for FDA granting Fast Track status for this investigational new drug?
A. Preliminary evidence indicates the new drug may decrease clinically significant toxicity of available treatment
B. Cancer is considered by FDA to be a serious diseaseC. Preliminary evidence indicates the new drug has potential for superior effectiveness co
mpared to available treatmentD. Documentation can be provided that the cancer drug meets safety and effectiveness sta
ndards required for Fast Track status
Answer: Dhttps://www.certs4you.com/raps/rac-us-dumps.html
Question No 8:
A company is evaluating next steps for a small Phase 1/2 clinical trial. There are four cohorts and the company has just completed enrollment of the third cohort. Efficacydata from immunology testing have revealed a small signal was detecte Based on these data; the company believes the fourth cohort should be dosed with a higherconcentration of drug product. The concentration required is higher than the current dose of the drug product and may not be supported nonclinical toxicology studies. The higher dose also will require some additional product development and the time to manufacture is estimated to be approximately 18 months. What is the best regulatoryapproach?
A. Recruitment on the current clinical protocol should be put on hold for two years to wait for the new drug product.
B. The current clinical protocol should be terminated and a new clinical protocol written with the new dosing supported by nonclinical studies.
C. The clinical protocol should be amended and increased dosing schedule be incorporated into the protocol.D. The clinical protocol should be amended and the dosing of the current drug product increased.
Answer: B https://www.certs4you.com/raps/rac-us-dumps.html
Question No 9:
A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form or strength, but anticipates the labeling will be identical to that of the RLWhat process should be used to apply for that permission from FDA?
A. Citizen PetitionB. Pre-NDA MeetingC. Suitability PetitionD. Notice of Opportunity for Hearing
Answer: C
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Question No 10:
Company X is planning to conduct a bioequivalence (BE) study for its proposed generic drug product. The clinical protocol requires a multiple-dose study where the totaldaily dose exceeds that specified in the labeling of the reference approved drug product. As a regulatory professional, which choice below is the correct action concerning this bioequivalence study?
A. The bioequivalence study may be started without further FDA action since the drug product is already the subject of an approved NDA
B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE Study
C. Request a Type B meeting with FDA for protocol review and approvalD. Submit a suitability petition requesting the use of the increased dosage range
Answer: Bhttps://www.certs4you.com/raps/rac-us-dumps.html
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