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In this week’s Pathways Picks: CMS-FDA RAPID proposal could be out this month; FDA issues draft guide on payor communications, and final guidance on human factors testing; China establishes standard framework for reclassifications; South Africa outlines what’s expected for electronic instructions for use; and more from South Korea, Europe, and the US.
On a panel at the annual Dublin Innovation Summit engaged stakeholders discuss the benefits and challenges of gathering deep data during the development and testing of therapies and diagnostics, specific to the gender of the patients who will benefit from the medical interventions.
The EU has launched its pilot breakthrough program. Excerpted from Pathways’ Picks May 8: Notified Body Rules, EU Breakthroughs, China Exemptions, and More.