139 – FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

This is a solo episode. On this episode, Subhi goes through:

01:51 Draft FDA Guidance – Platform TechnologyDesignation Program for Drug Development Guidance for Industry

13:03 EMA Guidance – Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulations on medical devices and in vitro diagnosticmedical devices (Regulations (EU) 2017/745 and (EU)2017/746)

18:25 USP – <1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products

20:10 Race Recap: Sugar Badger 50K

26:51 Conclusion

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he’s worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI’s Combination Products Committee. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.