Drugs

FDA, Other Agencies Ordered Back in Office

One of dozens of actions president Donald Trump took after being inaugurated 1/20 orders all government departments and agencies like FDA to end work-from-home arrangements and head back to the office “as soon as practicable.” Many FDA employees continue to work full-time from home or in a hybrid capacity splitting time between home and office after the Covid-19 public health emergency. The presidential memorandum orders agency heads to “take all necessary steps to terminate remote work arrangements and require employees to return to work in-person at their respective duty stations on a full-time basis, provided that the department and agency heads shall make exemptions they deem necessary.”

Since the pandemic, several agency officials endorsed the flexible working arrangements as improving morale, and helping to recruit and retain talented employees. During a 2022 Friends of Cancer Research (FOCR) program, now-former FDA commissioner Robert Califf said at the time that there was no need for 100% of agency staff to be back at White Oak headquarters as it was before the pandemic hit (see earlier story) “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 endorsed the hybrid environment where some work from home and others return to White Oak as they saw fit, and in-person meetings became an option for those in industry requesting them.

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

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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