While companies have been in contact with fda before they formally launch these, these applications for for these authorizations f d. That doesn't meanfda has all the data available to them, right? You know, they're talking to manufacturers, having conversations before the application actually crosses their desk. So while they may have an idea of what they're about to see, they don't have the full picture. Once fda gets that application, that's when the real work begins.
And how the seemingly endless wait in the US is affecting their development.
This episode was produced by Victoria Chamberlin, edited by Sean Rameswaram and Matt Collette, fact-checked by Laura Bullard and Victoria Dominguez, engineered by Paul Mounsey, and hosted by Noel King.
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