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FDA issues final guidance on predetermined change control plans for AI. Excerpted from Pathways’ Picks December 4: Action Packed in the EU, FDA AI Guide, and Global Picks.
New technologies are flourishing in the diagnostics industry, but finding money to fuel that innovation is getting tougher. Excerpted from our recent feature article, Diagnostic Start-Ups Post-COVID Reality.
FDA issued 31 draft and final guidance documents on January 6, just two weeks before the current HHS/FDA leadership exits and the Trump administration takes power. Several of the documents in particular should be on device companies’ radar: Excerpted from Pathways’ Picks January 8: FDA Guidance Bonanza, Diversity Action Plans, and Global Picks.
New technologies are flourishing in the diagnostics industry, but finding money to fuel that innovation is getting tougher. Excerpted from our recent feature article, Diagnostic Start-Ups Post-COVID Reality.