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FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

Despite its potential to slow cognitive decline, the delays highlight the challenges of timely drug approval for life-threatening conditions. The draft builds on prior FDA policies but introduces new provisions from the Consolidated Appropriations Act, 2023.

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How FDA’s AI Draft Guidance Aims to Bring Transparency to Drug Development

XTalks

Last year, Sanofi partnered with Formation Bio and OpenAI to introduce Muse, an AI-powered tool designed to accelerate patient recruitment for clinical trials. The possibilities of applying AI in drug development are vast and varied.