FDA Policy/General

FDA Lists Veterinary Regenerative Medicine Studies

FDA says it has created a Web page listing clinical field studies that are investigating animal cells, tissues, and cell- and tissue-based products (ACTPs) in veterinary patients. “The Web page provides animal owners, veterinarians, researchers, and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients,” an agency statement says.

Center for Veterinary Medicine director Steven Solomon says the Web page is being offered as a resource “because we’ve heard from veterinarians and pet owners who are eager to take part in clinical studies and avail their patients and pets of the potential that veterinary regenerative medicine may offer. Connecting interested pet owners and their veterinary teams with relevant clinical studies also helps sponsors in generating data toward potential FDA approval.”

The statement says that generally, the agency regulates ACTPs as animal drugs if they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or are intended to affect the structure or any function of the body of animals.

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