Devices

FDA Asked to Stop Some Dental Amalgam Use

The Campaign for Mercury Free Dentistry is asking FDA to stop amalgam use in children under age 15, pregnant women, and breastfeeding mothers. The petition says that the European Union recently took that action effective 7/1/18. But “the U.S. government has done nothing to protect these vulnerable populations from exposure to amalgam’s mercury,” it says. Specifically, the campaign asks the agency to:

issue a safety communication warning dentists, parents, and dental consumers against amalgam use in children, pregnant women, and breastfeeding mothers;
require manufacturers to distribute patient labeling that includes warnings against amalgam use in children, pregnant women, and breastfeeding mothers; and
develop and implement a public information campaign, including the agency Web site, social media, press releases, and a press conference, to warn dentists, dental associations, parents, and dental consumers against amalgam use in children, pregnant women, and breastfeeding mothers.

The petition lists eight developed countries that it says already have policies that discourage, restrict, or prohibit use of amalgam in children, pregnant women, and other sensitive populations. “Why are other countries protecting their children while FDA lets American children be exposed to dental mercury?” it asks. “In order to catch up with other developed nations, the commissioner must amend FDA’s mercury amalgam rule.”

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