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DUS ONLY Date Received: Approved/Disapproved Signature: BIO 395 Independent Work in Biology (13 Hours) Research Contract (to be used effective fall 2015) In order to receive credit for BIO395, students
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What is dus only - bio?
DUS Only - BIO stands for Data Universal Numbering System Only - Biological Product.
Who is required to file dus only - bio?
Manufacturers, repackers, relabelers, or individuals submitting a new drug application for a biological product are required to file DUS Only - BIO.
How to fill out dus only - bio?
DUS Only - BIO can be filled out electronically through the FDA's Electronic Submission Gateway (ESG) or manually by submitting a paper form.
What is the purpose of dus only - bio?
The purpose of DUS Only - BIO is to assign a unique identifier to biological products in order to track and monitor them throughout the distribution chain.
What information must be reported on dus only - bio?
The information reported on DUS Only - BIO includes the product's name, dosage form, strength, and packaging size.
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