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 US Food and Drug Administration (FDA). Dr. Gottlieb previously served as Deputy Commissioner for Medical and Scientific Affairs at the FDA, and his background includes experience in medicine, medical policy,…

Posted: June 2017 NCI to Team Up with Cancer Research UK and the Cancer Research Technology Pioneer Fund on RAS Research On April 19, 2017, Cancer Research UK (CRUK) and the Cancer Research Technology (CRT) Pioneer Fund announced a commitment of £2.5 million, or about $3.2 million, for a collaboration with the National Cancer Institute…

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 regarding more than 65 products being marketed with unproven or fraudulent claims. The products identified included pills, topical creams, ointments, oils, drops, syrups, teas, and a thermography device.1 The…

Posted: April 2017 By Erik T. MacLaren, PhD On January 11, the National Cancer Institute (NCI) launched a virtual agent formulary (NCI Formulary): a new public-private partnership designed to speed access to targeted therapies and combinations of cancer-fighting drugs by oncology researchers at the 69 NCI-Designated Cancer Centers. IASLC Lung Cancer News discussed the details…

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 US announced the Mutual Recognition Agreement to allow the FDA and the EU to accept one another’s inspections of drug and pharmaceutical manufacturing facilities, a change intended to reduce…

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 the evidence of safety and efficacy for all new drugs before they can be made available to patients. Increasing the efficiency and speed of the approval process for…

Posted: February 2017 By Erik J. Maclaren, PhD 2017 Mesothelioma Clinical Trials Planning Meeting Malignant mesothelioma is one of the most difficult cancers to control using existing therapies. Due to the rarity of this disease, randomized trials for potential new treatments are lacking. In order to facilitate clinical trials in patients with malignant mesothelioma, the…

By Stephanie R. Land, PhD Tobacco cessation assistance, imperative for tobacco users who seek medical care,1 takes on even greater urgency for individuals who are undergoing cancer screening or treatment. Cigarette smoking and other tobacco use in these settings raise important questions about how tobacco use affects patients and their cancer therapy, how to design…

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 to include all tobacco products, including e-cigarettes, cigars, and hookah, and pipe tobacco. IASLC Drug Cancer News spoke with Mitch Zeller, JD, Director of the FDA Center for Tobacco Products…

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 Mutation Test v2 to detect mutations in the epidermal growth factor receptor (EGFR) gene using patient plasma samples. IASLC Lung Cancer News spoke with Reena Philip, PhD, Director of…