Discuss drug safety and risk management advisory committee


Assignment task: Can anyone give me the answer of this MCQS?

Which ONE of the following best describes who is responsible for serving as the primary point of contact for safety-related aspects (e.g., receipt of IND annual reports or DSURs, ICSRs) of new drugs?

1) The Drug Safety and Risk Management Advisory Committee

2) The head of the Office of New Drugs at FDA

3) The medical reviewer in your assigned FDA review division

4) No answer text provided.

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