Drugs

PETA Letter Hits at FDA Lab Animal 'Cruelty'

People for the Ethical Treatment of Animals (PETA) is urging FDA to move away from animal experiments in its laboratories and to use more non-animal, human-relevant research methods. In a 12/11 letter to FDA commissioner Robert Califf, PETA highlights what it calls numerous “egregious violations of animal welfare guidelines” at FDA laboratories, and asks that the agency move to alternative methods that have the potential to provide both more timely and more predictive information to help accelerate product development.

The letter says that while FDA recognizes the severe limitations of animal experiments and the benefits of alternatives, only $5 million was allocated for “reducing animal testing through alternative methods” in the agency budget proposal for FY 2023, which included $77 million for the National Center for Toxicological Research and almost $56 million allocated to the White Oak Complex. “We ask that you address the treatment of animals in FDA laboratories and revise how the agency spends taxpayer dollars on experiments by implementing PETA scientists’ Research Modernization Deal — a strategy for replacing animal experiments with modern, human-relevant, animal-free research methods,” the group says.

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