FDA Policy/General

FDA Planning White Oak Return Under Hybrid Approach

FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur say FDA employees, who have been working from home during the pandemic, can likely return to the agency headquarters campus in White Oak, MD under a flexible hybrid approach in the near future. During a joint conversation at the 2022 Friends of Cancer Research (FOCR) in Washington, DC 11/17, the two senior leaders at the agency agreed that its workforce, like many workforces in other industries, has experienced a seismic shift that has opened up a new way of working.

Califf said he is finalizing FDA’s next steps and that there is no need for 100% of agency staff to be back at White Oak as it was before the pandemic hit. “We have a lot of evidence about satisfaction with the job, but also productivity and the expectations of the industries that we regulate,” he said, adding that industry has been adamant about returning to in-person meetings. Califf said that for now there will be a hybrid environment where some will work from home and others can return to White Oak as they see fit, and in-person meetings will become an option for those in industry requesting such.

Supporting the hybrid approach with a great degree of flexibility, Pazdur said that it “makes no sense for us to go back to White Oak and then open up a computer and have a meeting on a computer when half the people are not there at White Oak, so to speak. So, it really introduces kind of a new way of working, and this is not unique to the FDA, but it’s going to be unique throughout multiple industries… So, this mentality needs to be really looked at, of what we’re doing, why we’re doing it, and many people that are involved in intellectual pursuits, obviously, work outside of this nine-to-five mentality, and they’re thinking about things throughout the day, throughout the weekend, etc. So, we really have to be cognizant that it’s just going to be a different workforce.”

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