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Regulatory Affairs Certification (RAC) US exam dumps, RAC-US dumps torrent

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q37-Q42):

NEW QUESTION # 37
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

A. Cross-over
B. Placebo-controlled
C. Dose-ranging
D. Active-controlled

Answer: A

NEW QUESTION # 38
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

A. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
B. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
C. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation
D. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

Answer: C

NEW QUESTION # 39
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
B. Consult with the legal department to discuss the best course of action.
C. Request a meeting with the regulatory authority to discuss the application.
D. Review the regulatory guidelines to determine how to proceed.

Answer: C

NEW QUESTION # 40
The requirements for document control are located in which of the following documents?

A. ICH guidelines
B. WHO guidelines
C. IEC 60601
D. ISO 13485

Answer: D

NEW QUESTION # 41
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

A. Specification
B. Formulation
C. Property
D. Justification

Answer: D

NEW QUESTION # 42
......

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