FDA Corner

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

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...

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...

Interview with Richard Pazdur, MD

New oncology drugs have, for decades, followed a well-trodden path of sequential clinical trials to get from the laboratory to the patient. This model...

Interview with Mitch Zeller, JD

BY ERIK J. MACLAREN, PHD In May 2016, the U.S. Food and Drug Administration (FDA) finalized the deeming rule that extended the agency’s regulatory authority...

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...

FDA Corner – Interview with Amy Mckee, MD

Posted: February 2017 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...

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

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

FDA Corner – Interview with Commander Jason Humbert

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

Meeting News