It’s always been more art than science to determine the point at which “approvable” letters morph into “not-approvable” ones. This has often been held up as Exhibit A in the lexicon of the FDA’s lack of predictability.
And now the agency has addressed it head on. From now on there will be no more gradations of approvability. Say hello to the “complete response” letter.
Sound familiar? It should, it’s the same concept behind BLAs. In other words, the agency is embracing the concept of consistency. Good move.
Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.
And now the agency has addressed it head on. From now on there will be no more gradations of approvability. Say hello to the “complete response” letter.
Sound familiar? It should, it’s the same concept behind BLAs. In other words, the agency is embracing the concept of consistency. Good move.
Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.
