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NEW QUESTION 33
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request an inspection from a regulatory authority.
- C. Request documentation from the sub-contractor.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 34
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. In vitro studies show the product to be superior.
- B. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- C. Results of a three-year, post-market patient survey indicate the product is superior.
- D. Government survey data indicate the product is superior.
Answer: B
NEW QUESTION 35
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The ISO technical committee in charge of the area
- B. The ISO Secretariat
- C. The ISO national member body
- D. The country's regulatory authority
Answer: C
NEW QUESTION 36
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Vigilance procedure to notify the regulatory authorities about serious incidents
- B. Systematic procedure to review published scientific journals
- C. Systematic procedure to review experiences with the products in use
- D. Vigilance procedure to ensure the full traceability of the products
Answer: D
NEW QUESTION 37
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?
- A. Develop a generic version of the drug.
- B. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Develop a better brand-name drug in the same class.
- D. Explore litigation strategy for patent infringements on the drug.
Answer: A
NEW QUESTION 38
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