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APPLICATION FOR Excluded Transfer of Ownership The application approval process may take up to twelve weeks.This application is to be submitted for any excluded transfer of ownership in accordance
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Who needs 21 cfr 31472?

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Any organization or individual involved in the manufacturing, distribution, or sale of drugs or pharmaceutical products in the United States needs to comply with 21 CFR 31472.

What is 21 CFR 314.72 -- Change in ownership of an application. Form?

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21 CFR 314.72 refers to the regulation that outlines the requirements for the submission of post-marketing studies or clinical trials for approved drugs in the United States.
Any sponsor of a new drug application (NDA) that has received FDA approval is required to file 21 CFR 314.72 regarding post-marketing studies.
To fill out 21 CFR 314.72, sponsors must provide specific details about the post-marketing studies, including objectives, study design, methodologies, and timelines, using the FDA's prescribed format.
The purpose of 21 CFR 314.72 is to ensure that post-marketing studies are conducted effectively to assess the safety and efficacy of approved drugs in real-world settings.
Information that must be reported includes the study design, objectives, proposed methods, and timelines for completion, as well as any interim findings or data.
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