superrific
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I think he's referring to stage 3 trials that occur after a medication is approved for use. The trials don't just stop: the medication is studied, in the field so to speak, to see if the data from earlier clinical trials is borne out, or if there are new problems that weren't uncovered earlier, or if there are potentially off-label uses to study.Can you translate this? Sounds as if you’re saying the FDA wants less frequent data from you to support something — some kind of pharmaceutical?
Are those submissions to the FDA currently on a regular cadence? Or sporadic as new data comes in and gets pushed out?
One important function of these trials is to assess safety over a long period of time. When a drug is first evaluated for safety, the study lasts for a year, I think. The other poster has far more insight on that than I do. But whatever the time frame -- a year, two years, 6 months -- none of the initial studies can study 10-year health impacts, or 20 year health impacts.
It's not a regular process, in the sense that there are statutory deadlines or a set cadence, but it's regular in the sense that it happens frequently and the FDA used to welcome all additional data.