Drugs

FDA Denies Petition on Oral Health Drug Monographs

FDA has denied an 8/2/17 American Dental Association petition asking the agency to open the rulemaking process to review and update five over-the-counter oral health drug product monographs. The petition said many of the monographs had not kept pace with the latest science-based testing standards,

The denial letter says the petition failed to provide sufficient detail or supporting data to justify rulemaking action at this time. “We agree that the marketing and regulation of OTC oral health drug products should be informed by the best available scientific knowledge and testing methods,” the agency wrote. “However, your petition does not state specific regulatory changes or supply evidence regarding validated test methods that would advance this shared goal…. Additionally, we decline to initiate rulemaking to update the monographs described in your request at this time due to the evolving legislative landscape for reforming FDA’s system of regulating OTC drugs…. In light of the significant possibility that this transformative shift in our authorities will occur in the near future, and the absence of sufficient data in your petition, FDA believes that initiating notice and comment rulemaking to amend the oral health monograph described in your petition is not the appropriate course of action at this time.”

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