Category: In the News

PMWC 2017 at Duke Co-Chair Ralph Snyderman, MD, introduced the two panelists for a discussion of “Increasing Patient Access to Investigational Drugs,” as the two leading people in the country working to make such drugs available to patients, and noting that for patients this is perhaps the best of times and the worst of times—best…

As part of our coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago, we spoke about patient participation in clinical trials with Julia Beaver, MD, acting director of the Division of Oncology Products 1, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, at…

The prescription drug user fee agreement that Congress must approve by the end of September is particularly important because it furthers some of the drug-approval process innovations in the 21st Century Cures bill passed in 2016. That bill requires the Food and Drug Administration (FDA) to take certain steps to incorporate biomarkers, real-world evidence, and…

EACH YEAR, the ASCO President chooses a theme for his or her term, which is not a trivial pursuit. Trying to think up something novel and catchy, yet not schmaltzy, is quite a challenge. However, in my year as Chair of the Scientific Program Committee for the 2010 ASCO Annual Meeting, then during my 3…

Since taking office, President Trump has done right by the scientific and patient communities by placing strong leaders at the Food and Drug Administration and the National Institutes of Health. After a four-month vacancy in the FDA’s top job, Dr. Scott Gottlieb now runs this essential agency, and Dr. Francis Collins is continuing his leadership…

The proposed budget unveiled Tuesday by the Trump administration doubles down on major cuts to biomedical research, fighting infectious disease outbreaks, health care for the poor, elderly and disabled, and prevention of HIV/AIDS.   It restates the goals of the “skinny budget” the administration released in March, which was widely condemned by scientists and public…

Executive Summary CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.   The US FDA wants to speed up its policy-making process to better keep up with the speed of scientific advances affecting drug reviews.   Center for Drug Evaluation…

The FDA Oncology Center of Excellence occupied a special place in the Obama White House moonshot program.   Amid the moonshot’s big goals, the FDA center was concrete, manageable, and modestly priced, a reorganization that promised to revolutionize the agency’s handling of everything cancer.   How is the place faring today?   Not well, by…

The U.S. Senate voted on Tuesday to confirm Dr. Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.   The Senate voted 57-42 in favor of Gottlieb, a conservative physician and former deputy FDA…

Enacting a federal right-to-try law that circumvents FDA’s oversight of access to unapproved therapies no longer looks like a sure bet. Still, the debate over right to try has stimulated initiatives to give more patients who have run out of alternatives the chance to try experimental drugs and medical devices.   Propelled by victories in…