3 ms·
But do they replicate how that "original data" was generated or gathered?
by jfk13 8y ago
But do they replicate how that "original data" was generated or gathered?
- Gibbon1 8y agoFriend of mine was working for a medical device group. One of the managers removed some negative patient data from the reports they filed with the FDA. The FDA when they figured it out responded with an outright rejection that was final.
- refurb 8y agoNo, because the FDA doesn’t have the resources to actually redo a trial. What they do is ask the manufacturer to lay out how they run the trial before they start. If you bring data back to the FDA that doesn’t match up (fewer patients, different measurements) you can expect a rejection.