Drugs

ADA Wants OTC Oral Health Monograph Review

The American Dental Association is asking FDA to open a public rulemaking process to review and update several over-the-counter drug monographs for oral health drug products. The petition asks for a review and update of the monographs on OTC Anticaries Drug Products, OTC Oral Healthcare Drug Products, OTC Oral Wound Healing Drug Products, OTC Nailbiting and Thumbsucking Drug Products, and OTC Internal Analgesic Drug Products.

“Many of the oral health-related OTC drug monographs have not kept pace with the latest science-based testing standards,” the petition says. “As a result, consumers are buying a new generation of OTC oral health products whose safety, strength, quality, and purity are based on decades old science…. We would all benefit from knowing that the oral health-related drug products sold OTC have met the latest and best available scientific standards for safety, identity, strength, quality, and purity. Updating these drug monographs would be an important step in that direction.”

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