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MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAP 5210.5 Rev.2 POLICY AND PROCEDURES OFFICE OF GENERIC DRUGS Review of Investigational New Drug Applications (Bonds) by
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Begin by providing a brief introduction to the investigational new, including its purpose and background.
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Next, outline the methodology and study design used in the investigational new.
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Evaluate the results obtained from the investigational new and summarize them.
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Discuss any potential risks or side effects associated with the investigational new.
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Who needs review of investigational new?
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The review of investigational new is required by regulatory agencies such as the FDA (Food and Drug Administration).
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The review is essential for ensuring the safety and efficacy of the investigational new before it can be approved for clinical trials or public use.
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Medical professionals and clinicians who are considering the adoption or recommendation of the investigational new may also require the review.
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What is review of investigational new?
The review of investigational new is a process by which regulatory authorities evaluate the safety and efficacy of a new investigational drug or medical device before it can be used in clinical trials.
Who is required to file review of investigational new?
Sponsors or manufacturers of investigational new drugs or medical devices are required to file the review of investigational new.
How to fill out review of investigational new?
To fill out the review of investigational new, sponsors or manufacturers must provide detailed information about the product, its intended use, and any potential risks or benefits.
What is the purpose of review of investigational new?
The purpose of the review of investigational new is to ensure that new drugs or medical devices are safe and effective for use in clinical trials.
What information must be reported on review of investigational new?
Information such as the product's chemical composition, proposed labeling, manufacturing process, and preclinical data must be reported on the review of investigational new.
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