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The eSubmitter-eCopies Tool creates an eCopy in real time that is consistent with the technical standards described in the eCopy guidance. The eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials. The tool guides you through the steps of adding the content and allows you to download a formatted eCopy onto a local drive. From there, you can send an eCopy to the FDA.
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Windows and Mac Users: The most recent validation module versions (for Windows and Mac) were released on November 20, 2020. Always ensure you have downloaded and are using the most recent version of the validation module at the time you are planning to submit your premarket submission.
Log into My Account and submit your billing change request. Or you may download and complete the Premium Billing Change Request form and fax or mail it to us using the contact information on the form.
Log into My Account and submit your loan or partial withdrawal request electronically. Or you may download and complete the Loan or Partial Surrender Request form. Please fax or mail it to us using the contact information on the form.
The GIS Open Data portal allows consumers to interact with data through charts, tables, and maps. The information can be of value to many governmental agencies, private businesses and the public. Use of these data require a general understanding of GIS. The data can be downloaded into spreadsheet format, KML, or shapefile. The Open Data site works best with either Firefox or Chrome and is available from 6 a.m. to 10 p.m. GO TO OPEN DATA PORTAL 041b061a72