FDA Policy/General

Judge Blocks Mass Federal Layoffs Pending Appeal

Northern California federal judge Susan Illston has extended by two weeks a preliminary injunction halting the Trump administration’s plans for further reductions in force at FDA and 21 other federal agencies while the case is being appealed. The late 5/22 decision is in response to lawsuits filed by labor unions, nonprofit organizations, and local governments challenging the administration’s efforts to downsize the federal workforce without congressional approval.

The Democrat-appointed judge's ruling emphasized that such sweeping changes require legislative cooperation, stating, "The court holds the President likely must request Congressional cooperation to order the changes he seeks." She further noted that the administration's actions could not circumvent Congress in executing large-scale structural changes.

The injunction mandates that affected employees be reinstated to their prior statuses, effectively pausing the implementation of the administration's reduction-in-force plans. The ruling affects major departments, including Health and Human Services, Transportation, Labor, Agriculture, and the Social Security Administration. The retrospective reinstatement relief was further stayed by the judge pending appeal.

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