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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-07-17
- Length: 40m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/145---Regulatory-Policy--Advocacy--Legislation--Combination-Product-Regulatory-Harmonization--IMDRF-and-Ikigai-with-Ryan-Hoshi-e2m3vn6

## Summary

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that industry stakeholders, from technical reviewers to policy teams, play a critical role in advocacy by commenting on draft guidance and engaging with regulators to streamline the development of complex drug-device combinations.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=1) Introduction: Subhi Saadeh and Ryan Hoshi
- [3:08](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=188) Ryan Hoshi's Career Evolution at the FDA
- [5:45](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=345) Legislative Frameworks and Global Harmonization Challenges
- [10:52](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=652) Recent FDA Legislation: FDORA and User Fee Reauthorizations
- [13:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=821) IMDRF Meetings and Regulatory Reliance Practices
- [21:43](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=1303) Combination Product Definitions and Policy Work
- [27:55](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=1675) Industry Advocacy, Education, and Stakeholder Engagement
- [33:47](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon#t=2027) Ikigai, Purpose, and Future of Harmonization

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

large enterprises

## Mentioned

- AbbVie (company)
- FDA (company)
- IMDRF (company)
- FDORA (other)
- PDUFA (other)
- MDUFA (other)
- ASTM (company)
- ISPE (company)
- FPF (company)

## Related episodes from other shows

- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [How to Construct an Effective Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.