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Harpreet Singh, MD

Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors.

• Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

  Clinical Trials - Regulatory

  Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

  Aug 03, ‘26 | 9 min read

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    Harpreet Singh, MD

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

  Clinical Trials - Regulatory - Oncology

  FDA's Vision for Multiregional Clinical Trials in Oncology

  Apr 07, ‘25 | 6 min read

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    Harpreet Singh, MD

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• Read: 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

  Feb 25, ‘25 | 8 min read

  • 

    Harpreet Singh, MD

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• Read: What Is an FDA Breakthrough Therapy Designation?

  Clinical Trials - Regulatory

  What Is an FDA Breakthrough Therapy Designation?

  Nov 04, ‘24 | 8 min read

  • 

    Harpreet Singh, MD

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• Read: The Dose Dilemma: Lessons from Sotorasib and the Future of Oncology Drug Optimization

  Clinical Trials - Oncology

  The Dose Dilemma: Lessons from Sotorasib and the Future of Oncology Drug Optimization

  Oct 11, ‘24 | 7 min read

  • 

    Harpreet Singh, MD

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• Read: Advancing Equity in Clinical Trials: Unpacking the FDA’s Diversity Guidance

  Clinical Trials

  Advancing Equity in Clinical Trials: Unpacking the FDA’s Diversity Guidance

  Sep 12, ‘24 | 6 min read

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  • Rosamund R.

    Harpreet S.

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• Read: FDA ODAC Vote: Key Changes for Perioperative Cancer Trials

  Regulatory - Oncology

  FDA ODAC Vote: Key Changes for Perioperative Cancer Trials

  Aug 01, ‘24 | 5 min read

  • 

    Harpreet Singh, MD

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