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End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

 
• By Bridget Silverman

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

• Source: Shutterstock

The US FDA Center for Drug Evaluation and Research’s novel approvals class of 2022 is notable for the absence of very fast reviews – approvals that come within six months of submission, or at least two months in advance of a priority review goal date – marking another way in which the year 2022 reversed course from the agency’s recent past.

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Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 
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Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.

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More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 
• By Bridget Silverman

Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.

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ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

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• By Bridget Silverman

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