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NEW QUESTION 34
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Introducing a new analytical method
- B. Strengthening a precaution to the product labeling
- C. Deleting a drug substance
- D. Deleting an ingredient of the drug product
Answer: B
NEW QUESTION 35
Which of the following claims would classify an apple as a drug?
- A. “It will make you look younger.”
- B. “It will whiten teeth.”
- C. “It will satisfy hunger.”
- D. “It will prevent colds.”
Answer: D
NEW QUESTION 36
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through a product-specific meeting
- B. After the enactment of the regulation, through the industry representative
- C. Before the enactment of the regulation, through formal comments gathering process
- D. Before the enactment of the regulation, through the industry representative
Answer: C
NEW QUESTION 37
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