Hardware Podcasts

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

Let's Combinate · 8 May 2024 · 41m

What this episode covers

Tony Watson, Vice President of Regulatory and Quality at Windgap Medical, discusses the evolution of combination product regulation, tracing the creation of the Office of Combination Products (OCP) and the impact of MDUFA on FDA structure and resources. He details his transition from FDA reviewer to industry roles at Biogen and Sanofi, highlighting the challenges of establishing device competency within large pharmaceutical organizations and the unique supply chain dynamics of startups like Windgap. Watson emphasizes the critical importance of a 'combination product mindset' that balances drug and device perspectives, fostering a culture where dissenting opinions are heard to ensure quality and safety.

Most relevant to

early-stage companies and large enterprises

Topics

Mentioned

Companies
Windgap Medical, FDA, Biogen, Sanofi, Eli Lilly, Novo Nordisk, AbbVie, CDER, CDRH
Also
MDUFA, Part 812, GHTF, IMDC

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