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NEW QUESTION 52
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. Label the product for use in appropriate populations.
- B. Delay product launch until required studies are completed.
- C. Promote off-label use to a carefully selected patient population.
- D. Educate patients and healthcare providers on how to use the product
NEW QUESTION 53
Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?
- A. Enter into an agreement with Company Y to perform due diligence.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Recruit a professional to gather confidential intelligence on Company Y.
- D. Perform a thorough library search to gather detailed information on Company Y.
NEW QUESTION 54
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. Ask the vendor to take responsibility.
- B. Document and perform audits.
- C. Request an inspection from a regulatory authority.
- D. Request documentation from the sub-contractor.
NEW QUESTION 55