Drugs

Drop Rabbit Pyrogen Test References: Petition

Animal Defenders International (ADI) is petitioning FDA to revise its regulations to remove prescriptive references to the rabbit pyrogen test (RPT) for testing drugs for pyrogenic substances and to permit the use of validated non-animal methods instead. The petition says that continuing to refer to the rabbit pyrogen test in agency regulations is no longer scientifically, ethically, or regulatorily justified.

“Extensive evidence demonstrates that the RPT is limited in reliability, reproducibility, sensitivity, specificity, and human relevance, while modern non-animal alternatives, such as the MAT (monocyte activation test), provide scientifically superior and more human-relevant approaches to pyrogen testing,” it says. “Continued reliance on the RPT also imposes substantial animal welfare, operational, and economic burdens despite the availability of validated alternatives.”

ADI says that removing the FDA references would align the U.S. with major international regulatory developments, as both the European Union and the United Kingdom have already removed the RPT from their pharmaceutical frameworks, reflecting growing global scientific consensus that RPT testing is outdated and unnecessary.

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

Read more

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