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‘The house that Jack built’: remembering Howard University’s Jack E. White
FreeIn the Archives

‘The house that Jack built’: remembering Howard University’s Jack E. White

By Robert A. Winn, MDDirector and Lipman Chair in Oncology, VCU Massey Cancer Center,Senior associate dean for cancer innovation, VCU School of Medicine,Professor, Division of Pulmonary Disease and Critical Care Medicine,Virginia Commonwealth University;Guest editor, The Cancer History ProjectAsk members of the oncology community about the Howard University Cancer Center (HUCC), and more than 70 years later they will more than likely mention the man who laid the foundation for it.
Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”
FreeTrials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).