Citeline Podcasts

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In 2018 the US FDA and the Medical Device Innovation Consortium (MDIC) embarked on a mission to recast corrective and preventive action – CAPA – as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. On this week’s podcast we talk about the latest in those efforts, including a pilot program that’s testing a risk-based CAPA framework.

Medtech Insight articles addressing topics discussed in this episode:

• Not Your Grandfather’s CAPA: Case For Quality Pilot Gives Corrective And Preventive Action A Facelift

• How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'

APAC Podcast Episode 3: Coronavirus Impact, Vaccines, Remdesivir Moves by Pharma Intelligence

On this week’s podcast we talk about steps the agency is taking to begin conducting in-person surveillance audits again in the US.

Medtech Insight articles addressing topics discussed in this episode:

• When Will FDA Inspections Resume? Agency Looks To CDC, White House For Guidance

• No Firings, No Furloughs: FDA Staff Weathering COVID-19 Pandemic

In this week’s podcast, Medtech Insight's deputy editor Reed Miller highlights trial results from Boston Scientific and Medtronic at HRS 2020. Marion Webb discusses the impact of COVID-19 on Q1 2020 earnings results of major orthopedics companies.

Pink Sheet reporter and editor discuss the virtual appearances by US FDA Commissioner Stephen Hahn and others on Capitol Hill, GOP right-to-try questions for former BARDA Director Rick Bright, and new BIO CEO Michelle McMurry-Heath.

On this week’s podcast we talk about further steps the US Medicare agency CMS is taking when it comes to expanding testing for COVID-19. We also discuss how the pandemic is wreaking havoc on planned meetings by the US FDA and industry groups.

Medtech Insight articles addressing topics discussed in this episode:

https://medtech.pharmaintelligence.informa.com/MT126702/CMS-Expands-Coronavirus-Testing-By-Allowing-NonPhysicians-To-Order-The-Diagnostics

https://medtech.pharmaintelligence.informa.com/MT126592/CMS-Doubles-Up-On-Test-Reimbursements-Will-Pay-Labs-100-Per-Test-For-COVID19-Clinical-Diagnostic-Ass

https://medtech.pharmaintelligence.informa.com/MT126648/Latest-Coronavirus-Bill-Passage-Adds-$100Bn-To-National-Testing-Effort

https://medtech.pharmaintelligence.informa.com/MT126602/MDUFA-Meeting-Postponed-Again-Due-To-COVID19-This-Time-Indefinitely

https://medtech.pharmaintelligence.informa.com/MT126679/No-End-In-Sight-FDA-Postpones-Another-InPerson-Meeting-Due-To-COVID19

https://medtech.pharmaintelligence.informa.com/MT126613/AdvaMed-CEO-Says-Some-Top-Agenda-Items-For-the-Year-Are-Taking-A-Back-Seat-To-Address-COVID19

Pink Sheet reporters and editor discuss the potential trade-offs associated with speedy coronavirus vaccine development, changes in FDA approval volume since mass-teleworking began, and a study showing the Part D donut hole fix is not keeping up with price increases.

In this edition of the Device Week podcast, Medtech Insight’s Marion Webb and Reed Miller discuss how Edwards Lifesciences is handling the postponement of most transcatheter aortic valve replacement procedures during the pandemic and how it is planning to help customers complete these procedures by the end of 2020.

Medtech Insight articles addressed in this episode:

Edwards Sees ‘Tough Time’ Ahead For TAVR Patients

https://bit.ly/3cZk0fZ

Wall Street Tries To Guess The Impact Of Pandemic On Medtech Revenues

https://bit.ly/2UwqbAQ

UK Court Blocks Edwards’ TAVR Device For Patent Infringement

https://bit.ly/2y3CCNk

Gilead is set to release pivotal data for its antiviral remdesivir. But will the drug really play a decisive role against coronavirus? Plus an interview with Carl Hansen, CEO of AbCellera, one of several companies racing to find an antibody drug which could provide ‘passive immunity’ against coronavirus while we await a vaccine. Plus analysis of the first quarter impact of the pandemic on biopharma business, and reasons to be cheerful during the lockdown.

Hosted by Andrew McConaghie, Sarah Karlin-Smith and Kevin Grogan from the Scrip Pharma Intelligence team in the UK and Beijing.