FDA Corner

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

FDA Corner – Interview with Gideon Blumenthal, MD

By Erik J. Mac Laren, PhD In 2015, the US Food and Drug Administration (FDA) approved an unprecedented 7 new drugs or new uses for...

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...

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,...

The Upcoming Lung Cancer Neoadjuvant Meeting

(Photo: Gideon Blumenthal, MD, Nicole Drezner, MD, Mark G. Kris, MD) By Erik J. MacLaren, PhD Posted: February 2018 The development of immunotherapies and targeted therapies for use...

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...

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 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,...

FDA Corner – Interview with Reena Philip, PHD, and Eunice Lee, PHD

By Erik J. MacLaren, PhD Liquid Biopsy Testing On June 1, 2016, the U.S. Food and Drug Administration (FDA) approved the use of the cobas EGFR...

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