FDA Policy/General

New FDA Building Completed as DOGE Cuts 27 Others

As the Trump Administration is eyeing the closure of 27 FDA field offices across the U.S. under Elon Musk’s Department of Government Efficiency (DOGE) cost-cutting actions (see earlier story), the U.S. Army Corps of Engineers (USACE) just announced the successful completion of a construction project at the agency’s San Juan District complex. The project includes a new two-story, 11,000 square-foot annex building, alongside the remodeling of a sample room and a wellness room at the existing facility. FDA Webview sought comment from HHS on whether the new facility will receive a green light to become operational despite the recent cost-cutting, but received no response at press time.

“We are excited to announce the successful completion of the FDA construction project, which will enhance their operational capacity in Puerto Rico,” the USACE said in a release. “With a budget of $10 million, the new construction will consolidate administrative functions for the FDA San Juan Office. The renovated testing and sample room will allow the agency to maintain central space and necessary equipment in Puerto Rico, allowing them to prepare food samples collected locally to be sent later for testing to laboratories in the U.S.” The project will also advance FDA’s ability to protect and promote public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that emit radiation, it adds.

Meanwhile, DOGE has revised its savings estimates after trimming the earlier list of federal buildings targeted for lease cancelation. It has recently removed 91 federal sites previously listed on its “wall of receipts,” according to Fierce Biotech, which includes three FDA sites — St. Louis, MO, Columbus, OH, and Ontario, CA. In total, DOGE says it will save taxpayers around $350 million annually by terminating 657 government-wide leases.

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