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Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials

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CMO Confidential

3 FDA Approvals in 2025 That Shift the Landscape for 2026

CMO Confidential

The FDA’s 2025 approvals of Dordaviprone, Enhertu and Itvisma highlight shifting regulatory and development expectations heading into 2026. In this CMO Confidential video, watch Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD, explain what these landmark decisions mean for sponsors preparing for upcoming FDA submissions in oncology and rare diseases. 

Accelerate oncology drug development with insights from Precision’s blog

Stay informed with the latest insights from Precision experts, who share insights, trends, and success stories from the front lines of clinical research.

Read: FDA's Vision for Multiregional Clinical Trials in Oncology FDA's Vision for Multiregional Clinical Trials in Oncology

Clinical Trials - Regulatory - Oncology

FDA's Vision for Multiregional Clinical Trials in Oncology

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    Harpreet Singh, MD

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Read: FDA's Project Optimus: What Pharma and Biotech Need to Know FDA's Project Optimus: What Pharma and Biotech Need to Know

Clinical Trials - Regulatory

FDA's Project Optimus: What Pharma and Biotech Need to Know

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    Harpreet Singh, MD

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Read: MHRA's International Recognition Procedure: Fast-Track Access to the UK Market MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

Clinical Trials - Regulatory

MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

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    John M.

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    Alex G.

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