By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to ...
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy ...
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