Devices

FDA Asked for Dental Amalgam Patient Labeling

The Campaign for Mercury Free Dentistry has petitioned FDA to amend its mercury amalgam rule to require patient labeling for dental amalgam. The petition urges the agency to require manufacturers to distribute patient labeling containing information on (1) amalgam’s mercury content; (2) amalgam’s risks to children and fetuses; (3) the damage amalgam can do to tooth structure; (4) the damage caused by amalgam in the environment; and (5) the benefits of mercury-free fillings.

Such labeling is required, the petition says, by the Minamata Convention that was signed by the U.S. on 11/6/13. That convention, according to the group, requires parties to “phase down the use of dental amalgam.”

“FDA concedes that giving patients labeling with ‘direct information that would include the presence of mercury in amalgam’ would result in ‘an expected reduction in mercury exposure,’ the petition says. “Yet FDA refuses to take this effective amalgam phase-down measure.”

The document also says that labeling is needed to conform to new international guidance from the United Nations Environment Program. And it says that it is recommended by some FDA advisory panel members and is needed to comply with an agency guidance on medical device patient labeling.

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