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by boyband6666 2032 days ago
It is not a trivial process, and these are ferrociously complex. Safety, Quality and Efficacy - each are hard to check. From how people are categorised in trials, how missing data rules are implemented, to how it is manufactured and the stability data. It doesn't take a year for no good reason. Yes this has been sped up massively, but steps have been abbreviated - let's not kid ourselves.

If interested, the FDA release all documentation - search for Drugs@FDA and find a recent medicine, and see just how much review it gets. You'll be surprised!