Drug Fix: ‘America First’ US FDA User Fees, Moderna’s Flu Vaccine Saga Continues

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump’s priorities and the concerns they raise (:31). They also consider the impact of the agency’s decision to review Moderna’s mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA’s Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA’s Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/