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Long Hot Summer For Novel Drug Reviews Forecast At US FDA

 
• By Bridget Silverman

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Pink Sheet Perspectives 2019 to 2020

The psychological pull of a year-end deadline helps to produce a regular boomlet of novel agent submissions to the US Food and Drug Administration every December, but the effect was especially pronounced in 2019. A high proportion of the candidates look destined for priority review, which means August 2020 features the user fee goal dates for an astounding 16 novel agents.

The Pink Sheet has identified nearly 50 novel agents with user fee goals on the 2020. (See chart below

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