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RPP Office received on: REVISION SUBMISSION Human Use VA Human Research Protection Program (RPP) NF/SG VHS Gainesville, FL (573) Please Print or Type Please check all items included in attached packet/Do

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1. Start by carefully reading the instructions provided for the revision submission. Make sure you understand the requirements and any specific guidelines.
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8. End the submission by summarizing the key points and reiterating the desired outcome. Express your willingness to collaborate or provide further information if needed.

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What is revision submission- human use?

Revision submission- human use is the process of submitting updated information or changes related to human use applications to regulatory authorities for approval.

Who is required to file revision submission- human use?

Any entity or individual involved in human use applications, such as pharmaceutical companies or researchers, may be required to file revision submission- human use.

How to fill out revision submission- human use?

Revision submission- human use forms can usually be filled out online or submitted physically with the required documentation and information.

What is the purpose of revision submission- human use?

The purpose of revision submission- human use is to ensure that regulatory authorities are kept up to date with any changes or updates related to human use applications, to ensure safety and compliance.

What information must be reported on revision submission- human use?

Information such as changes to dosage, formulation, labeling, manufacturing process, safety data, or clinical trial results may need to be reported on revision submission- human use.