Thursday, August 18, 2022 9:48:55 AM
New Drug Applications (NDA) require certification that trial registration is up-to-date (IND sponsor must submit an FDA Form 3674 to their IND file)"
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fictr.johnshopkins.edu%2Fwp-content%2Fuploads%2F2016%2F06%2FClinicaltrials-gov-ProgramPresentation_ICTR_20170316.pptx&wdOrigin=BROWSELINK
In other words, sponsors cannot file for an NDA for a drug if all the trial registration data is not up-to-date.
It's also true that sponsors can be fined almost $12,000 for every day they are late in updating the results, but sadly that's more honored in the breach than the observance.
“The saddest lessons of history is this: If we’ve been conned long enough, we reject any evidence of the con. It’s too painful to acknowledge, even to ourselves, that we’ve been taken. if you give a charlatan power over you, you never get it back.”
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