FDA Corner

Articles from the U.S. Food and Drug Administration about issues relevant to the field of thoracic oncology.

FDA Corner – Interview with Amy Mckee, MD

BY Erik J. Maclaren, PhD Breakthrough Therapy Designation and Mechanisms of Expedited Review The U.S. Food and Drug Administration (FDA) is responsible for reviewing the evidence...

Interview with Dara Corrigan, JD: United States to Implement Mutual Recognition Agreement with European...

*Erik T. MacLaren, PhD, is acknowledged for his editorial support of this article. On March 2, 2017, the European Union (EU) and the US announced...

FDA Corner – Interview with Commander Jason Humbert

FDA Warns of Fraudulent Cancer Drugs On April 25, 2017, the US Food and Drug Administration (FDA) issued warning letters to 14 companies regarding more...

In Speech to Agency, New FDA Commissioner Highlights Anti-Smoking Efforts

By Erik T. MacLaren, PhD On May 11, 2017, Scott Gottlieb, MD, was sworn in as the 23rd Commissioner of Food and Drugs of the...

New Strategy for Tobacco Regulation

By Erik J. MacLaren, PhD Posted: October 2017 On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new, multi-year strategy intended to...

FDA Fosters Understanding about Approval Process for Biosimilars

By Leah Christl, PhD, Associate Director for Therapeutic Biologics and Director of the Therapeutic Biologics and Biosimilars Staff, Center for Drug Evaluation and Research,...

INFORMED: An Interview with Sean Khozin, MD, MPH

Posted: December 2017 The Information Exchange and Data Transformation (INFORMED) initiative was launched by the U.S. Food and Drug Administration (FDA) and the Innovation, Design,...

FDA Approval Processes in the Era of Targeted Therapies: A Conversation with Dr. Richard...

Posted: December 2018 Richard Pazdur, MD, is director of the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence. Below, he discusses the current...

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