Hardware Podcasts

143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

Let's Combinate · 3 Jul 2024 · 29m

What this episode covers

Alan Stevens, Global Head of Complex Devices at AbbVie, and Rumi Young, Director of Regulatory Policy at Novo Nordisk, discuss the FDA’s new draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices. They explain the distinction between EDDOs, system-level design outputs, and device-dependent design outputs, emphasizing that this framework applies to both combination products and standalone drug delivery devices like infusion pumps and auto-injectors. The guests highlight the guidance's value in providing concrete examples and clarifying the identification process early in development to ensure consistency across FDA review teams and industry sponsors.

Most relevant to

large enterprises

Topics

Mentioned

Companies
AbbVie, Novo Nordisk, FDA, Genentech, AstraZeneca, CDRH
Products
auto injector, infusion pump, syringe, pen injector

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