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Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

 
• By Bridget Silverman

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Keeping Track Feature image

Manufacturing continued to be the Achilles heel of ophthalmic drug development as the US FDA issued a second complete response letter (CRL) for Valeant Pharmaceuticals International Inc.'s latanoprostene bunod eye drops citing continued manufacturing deficiencies at the company's Tampa, Fla., facility.

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

 
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Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
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Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story

 
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Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.

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