FDA Policy/General

FDA Antimicrobial Stewardship Blueprint Coming

FDA commissioner Scott Gottlieb says the agency will soon implement a new five-year blueprint for how it will build on existing programs to advance antimicrobial stewardship in veterinary settings. “We’ll expand on FDA’s existing actions, and launch some new programs,” he writes in a statement. “Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance.”

Gottlieb says the blueprint will be a five-year plan for the Center for Veterinary Medicine (CVM) and will include key goals, objectives, and actions that CVM will focus on during FY 2019-2023. He writes that the new agency activities will be aimed at addressing three goals:

aligning antimicrobial drug product use with the principles of antimicrobial stewardship;
supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and
enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.

Specific objectives and actions will be outlined in the plan, he says. “Some of the important issues to be addressed in this new plan include establishing appropriate durations of use of medically important antimicrobials, and bringing all dosage forms of medically important antimicrobials under veterinary oversight,” Gottlieb says. “We are also developing and advancing new strategies for promoting antimicrobial stewardship in companion animals.” The goals will be advanced in new guidance that FDA says it will develop with broad stakeholder input.

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