Contains notes and references for official FDA documents.
The official directory contains annotations of and notes on the documents and guidelines issued by the FDA.
The guides directory contains individual guides corresponding to specific areas of the FDA's jurisdiction that a member of the Nebula Biotech open source project may be interested in.
FDA documents are reference by their document number (DN) and section (§) in parentheses, sometimes with a link to the original document. Refer to the cheatsheet for clarifications of most references, abbreviations, and terminologies.
Honestly, just start poking around the Markdown files. We try to link to all sources, so you'll get a lot from just reading our notes and following source links. We plan to turn this into more structured and actionable data in the future. And we are accepting pull requests if you'd like to contribute to the knowledge base :)
ProTip: Use Prose.io to edit and read these notes in your browser.