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NEW QUESTION 27
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

• A. For at least two years after the last approval of an application in an ICH region
• B. Until the product has been discontinued from marketing in all ICH regions
• C. Three years after the last clinical study site was supplied with investigational drugs
• D. For a minimum of 10 years after completion of the clinical study

Answer: A

NEW QUESTION 28
Which of the following statements regarding the off-label use of drugs is CORRECT?

• A. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
• B. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
• C. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
• D. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

Answer: B

NEW QUESTION 29
Which of the following statements regarding export regulations for an approved product is CORRECT?

• A. The product must not be in accord with the specifications of the foreign purchaser.
• B. The product must not be in conflict with the laws of the country to which it is intended for export.
• C. The product must not be sold or offered for sale in domestic commerce.
• D. The product must not be labeled on the outside of the shipping package that it is intended for export.

Answer: B

NEW QUESTION 30
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

• A. Site license
• B. Product license
• C. Export license
• D. Import license

Answer: A

NEW QUESTION 31
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