Biologics

FDA Halts Some Cell Clinical Trials

FDA says it is halting and will review new clinical trials that involve sending American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients, sometimes without their knowledge or consent.” An agency statement says it took action due to “mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments, including adversaries.” It blames a data security rule finalized by the Biden administration in 2024 for the problem.

While the rule imposed export controls to limit sensitive data transfers to countries of concern, the notice says, the Biden administration specifically requested and approved a sweeping exemption that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas as part of FDA-regulated clinical trials. It says the exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party.

“The previous administration turned a blind eye and allowed American DNA to be sent abroad, often without the knowledge or understanding of trial participants,” says FDA commissioner Martin Makary. “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”

The notice says the agency is reviewing all trials that relied on the exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. It says it will not allow new trials that cannot meet those standards to proceed.

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