FDA Policy/General

FDA Monkey Study Axed Over Inhumane Treatment Concern

FDA commissioner Scott Gottlieb has ordered the termination of an agency-sponsored animal (monkey) study of nicotine exposure over inhumane treatment concerns. Four monkeys died and now the remaining animals have been placed in a permanent sanctuary home. Gottlieb said that an internal review team “will determine the safety and well-being of the animals involved in the study, assess the circumstances surrounding the animal deaths, and gather information regarding the conduct of the study to inform decision making as to whether a further independent investigation was appropriate.”

Gottlieb said FDA has already dispatched a team of experienced primate veterinarians and animal-care professionals to conduct a site visit at the agency’s National Center for Toxicological Research (NCTR) to make sure that the animals involved in the study were being properly cared for in appropriate facilities. “I also placed a hold on the initiation of any new animal research at NCTR until the outcome of our review,” he said.

So far, agency findings indicate that its animal program may need to be strengthened in some important areas. Gottlieb has now ordered an independent, third-party investigation of the agency’s animal research programs, starting with those conducted at NCTR. Additionally, he said the agency has established a new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under the agency's purview.

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