Drugs

FDA Soliciting PreCheck Pilot Applications

FDA says it will start accepting applications on 2/1 for the PreCheck Pilot Program, which it says is intended to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of U.S. manufacturing sites, and streamlining aspects of pharmaceutical manufacturing facility assessments before a specific product application. An agency statement, which includes a graphic representation of the program implementation roadmap, says the pilot will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities this year.

Facilities will be selected based on overall alignment with national priorities, such as the products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development, FDA says.

The agency says it is incorporating stakeholder feedback into the program design based on comments made at a 9/30/2025 public meeting on “Onshoring Manufacturing of Drugs and Biological Products” and from public comments to a Federal Register notice. “Overall sentiment regarding the PreCheck program was positive,” it says, “with industry requesting early engagement during facility development phases. FDA will create a more predictable regulatory pathway, accelerate domestic pharmaceutical manufacturing, and protect patient safety through the implementation of the PreCheck program.”

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