FDA to Z of Getting Your Product to the US

The MTPConnect Podcast

Jeff Gibbs is a Director at Hyman Phelps and McNamara – the largest law firm specialising in FDA issues, based in Washington DC. With four decades of FDA expertise he delivers crucial insights for medical technology companies aiming to crack the US market. Peaking to the podcast during his national tour for the MTPConnect seminar series, this US-based regulatory veteran shares his strategic tips on the FDA submission process, and discusses the dramatically shifting FDA landscape that could make or break your US market entry strategy.

Whether you're developing breakthrough medical technology or refining existing solutions, this episode delivers essential knowledge for anyone considering the US market. Subscribe to the MTP Connect podcast for more insights that will help your innovation journey from bench to bedside to global markets.

Chapters

1. Introduction to FDA Expert Jeff Gibbs (00:00:00)

2. Australian Innovation Ecosystem Impressions (00:01:51)

3. FDA's Changing Role in Innovation (00:04:21)

4. Political Shifts and Regulatory Impact (00:08:09)

5. Key Strategies for FDA Engagement (00:12:58)

6. American Clinical Trials Importance (00:20:10)

7. Value of External Regulatory Expertise (00:25:47)

8. FDA Breakthrough Designation Reality Check (00:30:36)