Online Access Free RAC-US Practice Test

You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

• A.No action is required since it is an off-label use.
• B.Discuss with regulatory authorities to investigate how to have the off-label indication approved.
• C.Advise the senior management to send a "Dear Dr." letter.
• D.File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

• A.100 patients for 12 months
• B.3.000 total patient exposures
• C.500 patients for three months
• D.200 patients for nine months

A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

• A.Concept development and validation
• B.Early technical design and product release
• C.Product release and validation
• D.Concept development and early technical design

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

• A.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
• 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 description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
• 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

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A.Production
• B.Regulatory
• C.Analytical
• D.Quality