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2026 › February › 18
FDA
5 months ago
Makary pointed to three bottlenecks: hospital contracting, ethical reviews and approvals and the Investigational New Drug applications process
FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal ⊖
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.
FDA chief Marty Makary says 'everything should be over-the-counter' unless drug is unsafe or addictive ⊕
Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.
U.S. FDA reverses course, will review Moderna's modified flu vaccine application ○
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine application, reversing an earlier decision.
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