Drug Fix: US FDA Versus Moderna And The Changing Role Of Refuse To File Actions

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s controversial decision to refuse to file Moderna’s mRNA-1010 seasonal influenza vaccine candidate, including the unusual public airing of grievances (2:10), the changing issues sparking RTF actions (5:51), the uncertainty created by the decision and how vaccine sponsors should react going forward (16:54). More On These Topics From The Pink Sheet Moderna Cites Changing Advice As US FDA Refuses To File Flu Vaccine BLA: https://insights.citeline.com/pink-sheet/vaccines/moderna-cites-changing-advice-as-us-fda-refuses-to-file-flu-vaccine-bla-SRLIEHHMOFEWFPTLYJCXFIF5FM/ HHS Defends US FDA Refusal To File Moderna’s Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/hhs-defends-us-fda-refusal-to-file-modernas-flu-vaccine-NULTQ6P6R5C6DDXZFMZROE3HRU/