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RAC BUNDLED Exams 2023/2024 with 100% correct answers
RAC Exam 2023/2024 with 100% correct answers RAC DRUGS exam 2023/2024 with 100% correct answers
[Meer zien]RAC Exam 2023/2024 with 100% correct answers RAC DRUGS exam 2023/2024 with 100% correct answers
[Meer zien]In which situation is an IND not required? 
 
A) You intend to conduct a clinical trial with an investigational new drug 
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 l...
Voorbeeld 3 van de 25 pagina's
In winkelwagenIn which situation is an IND not required? 
 
A) You intend to conduct a clinical trial with an investigational new drug 
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 l...
[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? 
[A] Agreement meeting 
[B] Determination meeting 
[C] Presubmission meeting 
[D] PMA Day-100 meeting - correct answer [A] Agreement meeting 
 
[Q...
Voorbeeld 4 van de 41 pagina's
In winkelwagen[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? 
[A] Agreement meeting 
[B] Determination meeting 
[C] Presubmission meeting 
[D] PMA Day-100 meeting - correct answer [A] Agreement meeting 
 
[Q...
Which of the following is considered part of the Device Master Record? 
A. Employee training record 
B. Labeling specifications 
C. Design reviews 
D. Calibration records - correct answer B. Labeling specifications 
 
Question Feedback: Labeling specifications are part of the DMR 
 
A company ...
Voorbeeld 4 van de 44 pagina's
In winkelwagenWhich of the following is considered part of the Device Master Record? 
A. Employee training record 
B. Labeling specifications 
C. Design reviews 
D. Calibration records - correct answer B. Labeling specifications 
 
Question Feedback: Labeling specifications are part of the DMR 
 
A company ...
You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based me...
Voorbeeld 4 van de 57 pagina's
In winkelwagenYou work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based me...
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. 
B Validation of sys...
Voorbeeld 3 van de 19 pagina's
In winkelwagenWhich of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. 
B Validation of sys...
Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? 
 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - correct answer C. CDRH 
 
In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The anti...
Voorbeeld 4 van de 36 pagina's
In winkelwagenWhich division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? 
 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - correct answer C. CDRH 
 
In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The anti...
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - correct answer A: Proof of efficacy 
 
Which amendments to the...
Voorbeeld 3 van de 17 pagina's
In winkelwagenWhich of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - correct answer A: Proof of efficacy 
 
Which amendments to the...
Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 
 
1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce 
labeling 
 
1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbran...
Voorbeeld 3 van de 21 pagina's
In winkelwagenAdministrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 
 
1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce 
labeling 
 
1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbran...
Facility Registration - Devices - within XX days of application or manufacturing - correct answer 30 days 
 
Facility Re-Registration - Devices, Drugs & Biologics - correct answer Annual 
 
GLP & GCP Record Retention - correct answer 5 Years - from application or 
2 Years - from approval or t...
Voorbeeld 1 van de 4 pagina's
In winkelwagenFacility Registration - Devices - within XX days of application or manufacturing - correct answer 30 days 
 
Facility Re-Registration - Devices, Drugs & Biologics - correct answer Annual 
 
GLP & GCP Record Retention - correct answer 5 Years - from application or 
2 Years - from approval or t...
Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. 505 (B) 1 &2 - correct answer 21 CFR 314.54 
 
WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? - correct answer · An application that is a duplicate...
Voorbeeld 2 van de 11 pagina's
In winkelwagenProcedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. 505 (B) 1 &2 - correct answer 21 CFR 314.54 
 
WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? - correct answer · An application that is a duplicate...
drug - correct answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. 
 
medical device - correct answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any co...
Voorbeeld 3 van de 20 pagina's
In winkelwagendrug - correct answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. 
 
medical device - correct answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any co...
(EU) MA - correct answer Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 
 
4 EU procedures to obtain an MA - correct answer National, centralised, mutual recognition, decentralized procedures 
 
MAH - correct answer A legal perso...
Voorbeeld 1 van de 4 pagina's
In winkelwagen(EU) MA - correct answer Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 
 
4 EU procedures to obtain an MA - correct answer National, centralised, mutual recognition, decentralized procedures 
 
MAH - correct answer A legal perso...
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: 
A. 5 calendar days. 
B. 15 calendar days. 
C. ...
Voorbeeld 4 van de 39 pagina's
In winkelwagenA physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: 
A. 5 calendar days. 
B. 15 calendar days. 
C. ...
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - correct answer C 
 
A company wants to modify its legally marketed device such that the modification does not affect the intended use or alt...
Voorbeeld 3 van de 18 pagina's
In winkelwagenWhich division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - correct answer C 
 
A company wants to modify its legally marketed device such that the modification does not affect the intended use or alt...
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