https://github.com/nightscout/fda-presubmission

community maintained FDA presubmission
https://github.com/nightscout/fda-presubmission

Last synced: about 2 months ago
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community maintained FDA presubmission

• Host: GitHub
• URL: https://github.com/nightscout/fda-presubmission
• Owner: nightscout
• License: bsd-3-clause
• Created: 2014-06-24T21:24:25.000Z (over 10 years ago)
• Default Branch: master
• Last Pushed: 2015-01-18T21:09:04.000Z (almost 10 years ago)
• Last Synced: 2024-04-17T09:53:33.591Z (9 months ago)
• Language: Python
• Size: 3.4 MB
• Stars: 5
• Watchers: 13
• Forks: 1
• Open Issues: 2
• Metadata Files:
  • Readme: README.md
  • License: LICENSE

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# nightscout fda presubmission

sphinx presub ecopy source

Simple project to hold the content for an FDA presubmission.

All text.

It should:

  * communicate to the FDA description of what we are interested

  * List of unanswered questions for the FDA to answer

The description should give enough information to set context for the

questions, and allow them to assign an knowledgeable team to answer

the questions.