Foundations · How the agency works
Learn the work.
Then do it.
Free. Practitioner-written.
The free explanations of this profession are mostly written by tool vendors. These are written by people who do the work, sourced to the regulation, and pitched at someone who already knows what the FDA is.
FROM THE LIBRARY
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Every lesson answers one question properly, cites the regulation it rests on, and assumes you are here to do the job rather than to skim.
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Every lesson is tagged to the work it serves. Start where your product lives.
Drugs
INDs, NDAs & the CDER lifecycle
From first-in-human to approval — the submissions, the clocks, and the data behind them.
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Devices
510(k), PMA & the CDRH pathways
Predicates, substantial equivalence, and what clearance actually permits.
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Foundations
The concepts everything rests on
The framing, vocabulary and mechanics that make the rest of the library make sense.
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