FDA Policy/General

CDER Workplace Harassment, Civility Task Force

CDER director Janet Woodcock says the Center is launching a Task Force on Workplace Harassment and Civility as part of its commitment to a safe and respectful work environment. An e-mail from Woodcock to Center staff says the task force “will initiate critical assessments that will support longer-term efforts to explore staff perspectives and attitudes about harassment, discrimination, incivility, and bullying, including how we can prevent negative behaviors and promote workplace quality.”

In coming months, Woodcock says, Center employees will have an opportunity to complete a survey and provide anonymous feedback, and also to participate in discussion groups that will learn more about employees’ views and experiences. After that assessment phase is completed, she says, the task force will make recommendations and assist in implementing a Center-wide action plan that will support an approach to sustain a safe and inclusive environment in CDER.

“How we treat each other matters,” Woodcock concludes. “It has a direct impact on the physical and mental well-being of our staff. I want to assure you that senior leadership is committed to a civil workplace for all. I encourage your participation in this effort to help us keep to this commitment.”

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