Drugs

FDA Touts ImportShield Results

FDA says its ImportShield Program, formerly known as the Nationalized Entry Review Program, increased processing speed by 66%, increased monthly volume capacity by 33%, and reduced staff hours by 20%, all in its first four months of operation (since 8/2025). An agency statement says the new program “streamlines FDA’s import review process by combining five separate regional teams into one centralized operation. This new unified team provides consistent oversight across all U.S. ports of entry. By leveraging time-zone coverage and focused commodity expertise under unified management, the program improves efficiency, consistency, and accountability in import decision-making.”

“Whether it’s detecting counterfeit medications or identifying contaminated food products, the FDA ImportShield program and other modernization efforts add a powerful new layer of protection for American families,” says FDA commissioner Marty Makary.

FDA says that when it discovers high-risk products at one port, all other ports are alerted so they can prevent similar products from reaching consumers.

Elizabeth Miller, FDA associate commissioner for inspections and investigations, is quoted as saying FDA’s import review workload has grown substantially, with admissibility decisions increasing from 58 million lines in 2024 to 75 million lines in 2025. “The FDA ImportShield program helps the agency tackle this volume increase more efficiently,” she says.

According to the statement, the agency is also pursuing comprehensive technology modernization, including an advanced review platform system that will for the first time integrate multiple tools and databases, enabling staff to access comprehensive information more quickly while maintaining existing connectivity with Customs and Border Protection systems.

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