Commissioner Hahn’s role in the EUA for convalescent plasma has understandably roiled the world of FDA watchers. But what about the EUA that FDA still has not granted as a treatment for COVID-19?
The US Food & Drug Administration Emergency Use Authorization process will certainly be revisited when the time comes to apply lessons learned amid the COVID-19 pandemic.
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FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.
The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.
Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.
