Create submissions in Pepper Flow to help prepare 2253 submissions to the FDA. Submissions can include files from Pepper Flow, their linked references, uploaded supported materials, and an auto-populated 2253 form.
- Click "Submissions" in the navigation.
- Click "Create submission." The number next to the button represents approved documents that should be submitted to the FDA, but have not yet been included in a submission.
- Select the checkbox next to the file(s) you’d like to include in your submission.
- If applicable, check the options to include references and/or supporting materials that were uploaded in the Viewer.
- Click "Start submission."
Pepper Flow will take you to your submission, where you can make edits and download the 2253 form.
See the entire submission process in action:
Unzip files on Windows 10
The default unzipper on Windows 10 is unable to open documents with file names that contain extended or double-byte characters, like apostrophes. If you have trouble unzipping a submission, try using a different program, such as Winzip, 7-Zip, or ZipGenius, to open the zip file instead of the default unzip tool.