FDA Policy/General

Comments Sought on Antimicrobials Used in Animal Feed/Water

Federal Register Notice: FDA is seeking comments on establishing appropriately targeted durations of use for antimicrobial drugs which are important for human use, when they are administered in the feed or water of food-producing animals for therapeutic purposes. The request for comments is part of the government’s National Action Plan for Combating Antibiotic-Resistant Bacteria. FDA says its current methodology for assessing antimicrobial risks associated with the use of antimicrobial new animal drugs in food-producing animals is premised on the concept that increasing the exposure of bacterial populations to antimicrobial drugs increases the risk of generating resistance to those antimicrobial drugs. Because feed- or water-use antimicrobial drugs are typically administered to entire herds or flocks of food-producing animals, such uses pose a higher risk to public health than the administration of such drugs to individual animals or targeted groups of animals, as is done with dosage form drugs. Comments are due by 12/13. To view this notice, click here.

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