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- FDA issues warning letters to drug makers and a lab over CGMP and GLP violationsFDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
- Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategyFormer FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…