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Myris Drugs & Biologics are electronic submissions required by the Food and Drug Administration (FDA) to provide information on drug and biologic products.
Manufacturers and sponsors of drug and biologic products are required to file Myris Drugs & Biologics submissions.
Myris Drugs & Biologics submissions can be filled out electronically through the FDA's Electronic Submissions Gateway (ESG) portal.
The purpose of Myris Drugs & Biologics submissions is to provide the FDA with information on drug and biologic products for regulatory purposes.
Information such as product details, manufacturing processes, clinical trial data, and labeling information must be reported on Myris Drugs & Biologics submissions.
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