Drugs

Deny Mifepristone Preliminary Injunction: FDA

FDA is asking a Texas federal court to deny a request for a preliminary injunction sought by the Alliance for Hippocratic Medicine and others to reverse the FDA 2000 determination that mifepristone is safe and effective for the medical termination of intrauterine pregnancy under certain conditions. FDA’s filing in opposition to the injunction request says the plaintiffs’ position is based on speculative allegations of harm offered in support of claims and arguments that are untimely, unexhausted, and without merit. “Plaintiffs’ motion for a preliminary injunction satisfies none of the requirements for the extraordinary relief they seek and should be denied,” the filing says.

FDA says the plaintiffs have not shown any likelihood of success on the merits and have failed to show they will suffer imminent and irreparable harm without a preliminary injunction. Granting the injunction, it says, would “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution. The balance of the equities and the public interest thus also strongly favor denial of plaintiffs’ motion.”

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