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This is a complicated question....
In general, FDA approval is required prior to general public use. It has to be 'proven' to be safe. Although lately, FDA approved drugs have been shown to be otherwise.
However, in the USA, there are laws in place for compassionate use of drugs that are FDA approved for an alternate uses that have shown promise in terminal and serious diseases. This may allow for use prior to FDA approval of full blown MD testing. Currently this applies to cortico-steriods, since they are approved for other purposes and as far as I know not FDA approved for MD specifically....although there have been lots of MD studies using them.
In either case, it has to be shown safe in the testing that is underway. It may never get to final trials and receive FDA approval, if it is not shown to be safe and effective. So there is a chance that it will never be manufactured.
Hope this helps.
Kevin |
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K. Goodfellow |
