Category: CDER

Death of a Euphemism: The End of FDA’s “Approvable Letter”

JGrimes
Approvable letter — that sounds pretty good, right? Like, basically, something is on the verge of a green light? Not if you get one from the FDA about a drug you hope to market.
When the agency sends a drug company an approvable letter, about the best you can say is that that your […]

Continued Read ...
Posted in diabetes, Drugs, FDA, CDER  

Death of a Euphemism: The End of FDA’s ‘Approvable Letter’

JGrimes
Approvable letter — that sounds pretty good, right? Like, basically, something is on the verge of a green light? Not if you get one from the FDA about a drug you hope to market.
When the agency sends a drug company an approvable letter, about the best you can say is that that your […]

Continued Read ...
Posted in diabetes, Drugs, FDA, CDER  

 
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