2 ms·
It’s because the publishing process takes more time than the FDA review process. Once the pivotal trial reads out, companies usually submit within a month or t
by refurb 1y ago
It’s because the publishing process takes more time than the FDA review process.
Once the pivotal trial reads out, companies usually submit within a month or two to the FDA. Much of the submission dossier (trial design, product description) can be written ahead of time, so it’s really the results that need to be drafted.
The FDA can approve in as little as 3-4 months for an accelerated approval, but it can take up to 12 months.
Compare that with a paper being written and reviewed across multiple authors (3-6 months if you’re lucky), then submitting to multiple journals for review and feedback (6 months), then final submission and peer review (1-2 months), then any additional edits (1 month), then final slating for publication after article is type set, all figures are sized, article laid out and final version (1-2 months).
So all in the FDA takes less time (3-12 months) than publishing (12-17 months).