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- Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA workAt the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
- FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancerThe U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…