Citeline Podcasts

The head of the US agency’s device center spoke with Medtech Insight in a wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.

In this bonus edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), speaks to the PAGB's Michelle Riddalls about the association's upcoming Digital Week event (5th to 9th July) and the promise of digitalization for the UK consumer healthcare industry. In this wide-ranging interview, we discuss how digital adoption by industry and consumers has been accelerated by the pandemic, as well as the opportunities and challenges of the recent e-commerce boom and how this highlights the need for consumer digital literacy. Social media influencers, mobile health apps and wearables and real-world data/evidence are all also on the agenda.

Scrip’s Five Must-Know Things – 28 June 2021 by Pharma Intelligence

In this edition of Device Week, Medtech Insight's UK-based reporter Barnaby Pickering provides an insight into Procyrion’s novel device for decongesting cardiorenal syndrome patients. US Commercial and R&D manager, Reed Miller, highlights details on Pear Therapeutics’ recent SPAC acquisition, and managing editor, Marion Webb, discusses two companies that received types of approval for novel devices.

Medtech Insight articles discussed in this week’s episode:

Onward Secures FDA Breakthrough Designation To Improve Movement, Quality Of Life After Spinal Cord Injuries

Start-Up Spotlight: Procyrion Trials Novel Device To Tackle Cardiorenal Syndrome

In this edition of HBW Insight's new 'Over The Counter' podcast, David Ridley (Senior Editor, EU), talks to Canna Consultants' Steve Oliver about the current state of CBD regulation in the UK and European Union. Specifically, we discuss what is going on with the hundreds of CBD novel food applications submitted to the UK Food Standards Agency and why only four synthetic CBD novel food applications have been validated by the European Commission so far. We also speculate about the possibility of CBD becoming an OTC medicinal ingredient in the future.

Podcast Time Stamps

00:08 Introduction

01:01 The spin-off from Merck: The world needs a company like Organon

03:13 Taking a broad view on women’s health - beyond reproductive health

05:24 Wall of Voices – Listening to the needs and challenges of women

10:32 Partnering and Inorganic Growth

12:51 The cultural fit for alliances

14:06 Majority-female board of directors

15:50 Renewed focus on established products portfolio, life cycle management

19:07 Biosimilars franchise

21:30 Putting women’s health high up on the agenda

Scrip’s Five Must-Know Things – 21 June 2021 by Pharma Intelligence

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we discuss the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month.

Medtech Insight articles addressing topics discussed in this episode:

• MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical

• ‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic

• IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows

• After 3 Years Of Work, FDA Says It Will Release Its Revamped Quality System Regulation This Month

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Barnaby Pickering and Danny Al-Faruque offer a recap of our digital health coverage in May and early June, including the latest Market Intel on the “Future of Surgery” focusing on immersive technologies, an interview with the author of “The Digital Pill” and US FDA news on Verily, Cognoa and cybersecurity standards.

Listen to the podcast via the player below:

Market Intel: How Augmented, Mixed And Virtual Reality Unveils New Possibilities For Surgeons

Market Intel: Medtechs, Surgeons Embrace ‘Virtual Operating Theater’ As New Reality

First-Of-Its-Kind Autism Software Could Help Diagnose, Treat Children Faster: FDA

Verily’s Study Watch Rejected By FDA As Parkinson’s Drug-Development Tool

FDA Says SBOMs Are Key To Better Cybersecurity In NIST Report

‘The Digital Pill’ Author Sees Digital As Catch-All Solution For Health Care

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Medtech Insight articles addressing topics discussed in this episode: