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by nknealk 1911 days ago
The FDA can (and will) audit anything and everything you do for approved drugs/treatments. There are no trade secrets in medicine. This is why companies patent things. You literally can’t hide information about something that’s about to be FDA approved.

As a result, the medical industry is less competitive than other industries. Also, it’s seen as ethically dubious to compete on saving lives. Instead, there’s a lot if in-licensing deals (see above re patents) as opposed to trade secrets.

2 comments

You can’t hide it from the FDA, but not everything the FDA sees is available to the public and competitors.
There are vast amounts of data that you have to disclose to FDA that you are permitted to mark as not for public disclosure. If you ever FOIA records from FDA they are heavily redacted.