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Pink Sheet Podcasts

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

Pink Sheet Podcast: Pre-Announced FDA Inspections, Vaccine Safety, On-Time Application Decisions

Pink Sheet reporters and editors consider the impact of pre-announced domestic inspections, as well as look at the various COVID-19 vaccine safety monitoring programs and new data on application decisions during the pandemic.

Pink Sheet Podcast: A Year Of The COVID-19 Pandemic, When Will Biden Nominate An FDA Commissioner?

Pink Sheet reporters and editors discuss the impact of the COVID-19 pandemic on pharma and the FDA and consider former commissioners’ pleas for President Biden to nominate a permanent agency commissioner.

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

Pink Sheet Podcast: COVID-19 variants and vaccine trial dropouts, Aducanumab, User Fee Goal Changes

Pink Sheet reporters and editor discuss the latest coronavirus vaccine news, CMS’ effect on the future of aducanumab, as well as new assessment goals for PDUFA VII.

Pink Sheet Podcast: COVID-19 Vaccine Dose-Sparing, New Viral Variants, CMS and FDA Leader Updates

Pink Sheet reporters and editor discuss Biden’s look at coronavirus dose-sparing strategies, FDA plans for vaccine adjustments in lieu of viral variants, new CMS administrator candidates and groups lobbying for the new FDA commissioner.

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Pink Sheet Podcast: Pharma Gets Democratic Senate, Slow COVID-19 Vaccinations, 2020 CDER Approvals

Pink Sheet reporters and editors consider the implications of a Democratic Congress for the pharma industry, ongoing problems with slow coronavirus vaccination rates, and the high CDER novel approval count in 2020.

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Informa Pharma Intelligence podcasts discuss key ideas and insights affecting biopharma and medtech, brought to you by our global team of editors. Listen on-demand to our perspectives on the latest industry developments.

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