Hardware Podcasts

145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

Let's Combinate · 17 Jul 2024 · 40m

What this episode covers

Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie, discusses the complexities of global regulatory harmonization for combination products, drawing on his prior experience at the FDA's CDRH and CDER. He explains how legislative frameworks like the Food and Drug Omnibus Reform Act (FDORA) and user fee reauthorizations (PDUFA, MDUFA) shape the regulatory landscape, while international bodies like the IMDRF work to align standards across sovereign jurisdictions. Hoshi emphasizes that industry stakeholders, from technical reviewers to policy teams, play a critical role in advocacy by commenting on draft guidance and engaging with regulators to streamline the development of complex drug-device combinations.

Most relevant to

large enterprises

Topics

Mentioned

Companies
AbbVie, FDA, IMDRF, ASTM, ISPE, FPF
Also
FDORA, PDUFA, MDUFA

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