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Speedier drug approvals hit slowdown as FDA faces scrutiny

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( ) -q-27- UNDATED (Correspondent Jeremy House) “codify those standards.”

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs.

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Out-cue: codify those standards]

TAG: Correspondent Jeremy House reporting. Many experts support the measures as a way to claw back unproven drug uses after a recent boom in accelerated approvals.

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VERBATIM: The downturn comes as the agency’s accelerated approval program comes under new scrutiny from Congress, government watchdogs and key agency leaders. Increasingly, the FDA is asking drugmakers to remove unproven uses from older drugs that haven’t delivered on early results. And drugmakers seeking accelerated approval for new medicines are facing tougher hurdles at the agency. Legislation pending in Congress would codify those standards.

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