Devices

Group Wants FDA Warning on Dental Amalgam

Consumers for Dental Choice has filed a citizen petition with FDA asking that the agency take steps to warn against amalgam use in children, pregnant women, and other sensitive populations by:

issuing a safety communication warning dentists, parents, and dental consumers against amalgam use in children, pregnant women, and other sensitive populations;
requiring manufacturers to distribute patient labeling that includes warnings against amalgam use in the specified populations; and
developing and implementing a public relations campaign to warn dentists, parents, and dental consumers against such amalgam use.

The petition says that FDA must take measures to warn against amalgam use in the three specific populations because (1) experts have found that amalgam poses a risk to the populations; (2) FDA has admitted that the three populations are at risk; and (3) the U.S. needs to catch up to other developed nations that are already taking action to protect their vulnerable populations.

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