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NEW QUESTION 51
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. No action is needed in this situation.
- B. Prepare regulatory submissions that detail the medical device’s change in materials.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Write a memo to file since the change does not impact product safety and effectiveness.
NEW QUESTION 52
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. 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.
- B. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer’s promotion for such use.
- C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- D. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
NEW QUESTION 53
A company’s product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Educate patients and healthcare providers on how to use the product
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Label the product for use in appropriate populations.
NEW QUESTION 54
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
- A. Submit the product for review as a pharmaceutical product in Country Y.
- B. Apply for review of the additional part of the product as a pharmaceutical product in Country
- C. Examine decisions made about similar products in Country Y to propose the classification of the product.
- D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
NEW QUESTION 55
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