FDA drafts guidance on demonstrating substantial evidence of

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Additionally, the guidance provides examples of approaches based around a single adequate and well-controlled study:

One adequate and well-controlled clinical investigation on a new indication for an approved drug, supported by existing adequate and well-controlled clinical investigation(s) that demonstrated the effectiveness of the drug for its other, closely related approved indication(s);
One adequate and well-controlled clinical investigation supported by data that provide strong mechanistic support;
One adequate and well-controlled clinical investigation with compelling results, supported by additional data from the natural history of the disease; and
One adequate and well-controlled clinical investigation of the new drug, supported by scientific knowledge about the effectiveness of other drugs in the same pharmacological class.

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