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US FDA Advisory Committee Drought Is Over … Unless Sponsors Are Scared Of Dark Clouds

 
• By Michael McCaughan

FDA has three NDAs set for public advisory committee review at the end of March and early April, the first 'real' committee meetings in five months. Oops. Make that two.

On March 29, FDA will host its first new drug application focused advisory committee meeting in almost five months – assuming a sponsor is willing to go through with it.

It has been a long time since FDA last held a public advisory committee review of a pending new drug application – the “typical” advisory committee that ends with an up or down vote on approval of a new product. In case you can’t remember that far back, the meeting was for Cempra’s novel antibiotic solithromycin on Nov. 4

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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