In 2006, the Food and Drug Administration launched a program to require drug makers to win approval of medicines that — believe it or not — were being sold without the agency’s imprimatur or remove them from the market. At the time, hundreds of treatments were readily available because some companies failed to comply with a 1962 law mandating companies prove drugs were effective.
Unfortunately, the FDA effort has had some unforeseen consequences.
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Is UDI why tetracycline went on shortage and there were significant price increases? Plaquenil?