India....This discussion about the need for blinded, placebo control trials has gone on for several years. The more current 21st CCA guidance points to the options of using "unblinded", non placebo trials when there is ample safety and "Natural History" data available for the trial. This also requires an unmet need for critical medical applications. Both Scott Gottlieb and Janet Woodcock have moved the FDA in this direction in order to get drugs, especially cancer drugs, to market more quickly. Below, is Dr Woodcock's testimony to Congress on modern 2!stCCA clinical trial architecture.
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