FDA Policy/General

Mike Taylor Leaving FDA, Ostroff to Take Over

FDA deputy commissioner for foods and veterinary medicine Michael R. Taylor will be leaving the agency 6/1 to look for work involving food security in developing countries. “I’m not retiring,” he told FDA Webview firmly, though he said he could not be more specific yet about exactly where he will land. “It’s been a great seven years,” he said of his recent time at FDA. His main focus until he leaves will be helping his successor, former acting commissioner Stephen Ostroff, settle in and take over the reins in his bifurcated office that coordinates the policy issues between CVM and the Center for Food Safety and Applied Nutrition (CFSAN).

According to a 3/8 CVM Constituent Update announcing the leadership changes, Taylor has spent the past six year leading the agency’s implementation of the FDA Food Safety Modernization Act, the most sweeping food safety reform in more than 70 years, overseeing in the process “the move to eliminate the use of certain antibiotics that can contribute to the development of antimicrobial-resistant bacteria. Understanding the importance of dialog, partnership and active stakeholder engagement in effecting change, Mr. Taylor has sought to ensure everyone has a place at the table in designing rules and taking actions to protect Americans and contribute to a safer, more wholesome food supply.”

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