FDA Corner

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

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 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 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 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 On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new, multi-year strategy intended to reduce tobacco-related...

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...

*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...

Meeting News