FDA Corner

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

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...

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...

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...

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...

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 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 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 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...

Meeting News