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...
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,...
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...
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...
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...
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 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 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...
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...
