FDA Policy/General

FDA Wants Antimicrobials Input

FDA is looking for public input on its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials used to treat human disease that are placed in animal feed or water that have at least one therapeutic indication without a defined duration of use. A statement says the agency wants information from the public about how to establish appropriately targeted durations of use for the estimated 32% of therapeutic products affected by a 12/2013 guidance that, when fully implemented, limits use of the drugs to therapeutic-only use under the oversight of a veterinarian. The duration of use information is needed to foster stewardship of medically important antimicrobial drugs in food-producing animals and help preserve the effectiveness of these antimicrobials in animal and human medicine, FDA says. Specifically, the statement says, for certain species and disease indications as listed in a still to be released Federal Register notice, the agency wants to obtain information on:

the underlying diseases requiring the drugs for therapeutic purposes, and periods when livestock or poultry are at risk for developing the diseases;
more targeted antimicrobial use regimens for the diseases and husbandry practices that may help avoid the need for the antimicrobials, or that may help make more targeted antimicrobial use regimens more effective; and
strategies for updating affected labeling of drug products that do not currently included a defined duration of use.

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