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Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

 
• By Derrick Gingery

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.

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Sponsors may desire breakthrough status because of the perks that come with it, but US FDA officials said promising non-breakthrough products also could receive a lot of attention to speed them to market.

Billy Dunn, director of the Office of Neurology Products, said his staff does not approach an application differently whether or...

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