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NEW QUESTION 29
The requirements for document control are located in which of the following documents?
Answer: B
NEW QUESTION 30
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
Answer: B
NEW QUESTION 31
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
instructions for storage and handling of the dosage form: and a description of the formulation
Answer: D
NEW QUESTION 32
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