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The Washington Post – Biden nominates Robert Califf, former Obama FDA chief, as agency commissioner

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Politico – Biden nominates Califf as FDA chief

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Regulatory Focus – Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity

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Regulatory Focus – White paper bolsters ctDNA as potential ‘early endpoint’ in cancer approvals

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Oncology Times – Rethinking FDA's Breakthrough Therapy Designation

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Bloomberg Law – Pandemic Opens Door to More Real-World Data for Drug Decisions

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Friends of Cancer Research Announces Results from Phase 2 of Tumor Mutational Burden Harmonization Project

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Politico – Biden’s new health challenge: Find another Francis Collins

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FierceHealthcare – Industry Voices—COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight

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Business Wire – National Cancer Institute Selects ImmunityBio’s N-803 IL-15 Receptor Agonist to Combine with Keytruda in 700-Site Lung-MAP Clinical Trial of a Chemo-Free Therapy

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The Cancer Letter – U.S. cancer patients gained 14 million life-years since 1980 because of NCI-funded trials

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Bloomberg Law – Shutdown Threat Clogs FDA Workload as Vaccine Push Continues

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Pink Sheet – Time To Simplify US FDA’s Expedited Pathways? It Won’t Be Simple

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Pink Sheet – Picture Is Worth 1,000 Meetings: ‘Snapshots’ Could Support ‘Breakthrough’ Dialogue At US FDA

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NPR – The FDA Has Been Without A Permanent Leader For 8 Months As COVID Cases Climb