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NEW QUESTION 20
Which term does NOT describe the same concept as the others?
Answer: B
NEW QUESTION 21
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
Answer: D
NEW QUESTION 22
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
Answer: D
NEW QUESTION 23
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
Answer: A
NEW QUESTION 24
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