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Nd\'BOMB APPROVAL
OMB Number:
32350123
Expires:
May 31, 2017,
Estimated average burden
hours per response...... 12.0017017792ANNUAL AUDITED REPORT
M×X17A_,5
PART III SEC FILE NUMBER8ASFACING PAGE/Information
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It is always best to check with the specific organization or agency that is requesting the NDI to ensure you understand if it is necessary for your particular situation.
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What is ndi?
NDI stands for New Drug Application, which is a request to the U.S. Food and Drug Administration to approve a new drug for sale and marketing in the United States.
Who is required to file ndi?
The pharmaceutical company developing the new drug is required to file the NDI with the FDA.
How to fill out ndi?
The NDI must be filled out following the guidelines provided by the FDA, including detailed information about the drug's composition, safety, and efficacy.
What is the purpose of ndi?
The purpose of the NDI is to provide the FDA with the information necessary to evaluate the safety and effectiveness of a new drug before it is approved for sale.
What information must be reported on ndi?
The NDI must include information on the drug's chemical composition, manufacturing process, preclinical and clinical studies, and proposed labeling.
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