Published 1 year ago

FDA proposes overhaul of fast-track process for cancer meds

Summary by Ground News

FDA proposes randomized controlled trials instead of widely used "single-arm studies" The agency's accelerated approval process has drawn fire for the way it allows manufacturers to launch products based on preliminary evidence and charge high prices before they complete trials. The comment period on the guidance runs through May 26.

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FDA proposes overhaul of fast-track process for cancer meds

The Food and Drug Administration is eyeing policy changes that could make drugmakers conduct more stringent trials to win fast-track approvals of cancer drugs.

1 year ago·Washington, United States

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