FDA Policy/General

Cancer Experts Endorse Woodcock for Commissioner

Some 94 oncology physicians, researchers, and leaders have signed a 2/11 letter to President Joseph Biden urging the selection of FDA acting commissioner Janet Woodcock to be the agency’s next commissioner. Those signing the letter include some who served on Biden’s Cancer Moonshot Blue Ribbon Panel when he was vice president.

“As leaders in oncology with decades of experience, we know that now, more than ever, FDA requires a strong and respected leader who has the deep understanding of science, public health, and drug development to steer the country through these unprecedented challenges,” the letter says. “Taking the next step and nominating Woodcock as FDA commissioner is the leadership we need to move forward in our deep understanding of science and would affirm to the American public that FDA will continue to be the global gold standard to change patients’ lives for the better. Woodcock is uniquely qualified to run FDA at this vital moment for the science and research taking place across the country. Many of us have known Woodcock throughout her decades of service as the director of FDA’s Center for Drug Evaluation and Research. We have witnessed her impeccable ability to lead the agency as it maintains the highest global standard for regulatory science, innovation, and protecting public health.”

Recently, support for Woodcock was voiced in a Los Angeles Times op-ed, while Public Citizen and 28 other advocacy groups notified Biden that they opposed her nomination.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome