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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 not it obtains breakthrough status.

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