FDA Policy/General

FDA Releases Animal Product Adverse Reports

FDA has released 30 years of adverse event reports related to animal drugs and medical devices used in animals. The reports are available online here. An agency announcement of the release says the action “is part of a broader effort by the agency to increase the transparency and sharing of adverse event report data related to the medical products that FDA regulates.”

Data in the release come from the Center for Veterinary Medicine’s adverse event reporting system, one of the postmarket surveillance tools that FDA uses to monitor the animal and human user safety of drugs and medical devices used in animals, as well as the effectiveness of the products.

FDA says the detailed level of data previously was available only through a Freedom of Information Act request. The initial release contains some 865,075 reports submitted between 1/1/1987 and 4/3/19. FDA says it plans to update the information quarterly and will also include voluntary reports from a variety of sources including pet owners, animal producers. veterinarians, and other healthcare providers.

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