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Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

 
• By Sue Sutter

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

Hand opens curtain to beautiful day

US FDA Commissioner Scott Gottlieb is laying the groundwork for public disclosure of complete response letters (CRLs) driven by safety or other concerns with "significant public health value" – a move that could at least partially lift the veil on why drug applications fail to gain the regulator's nod.

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

 
• By Bridget Silverman

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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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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