Drugs

Takeaways from FDA Monograph Reform Webinar

Over-the-counter drug monograph reform will take more than a few years to implement, given some of the timeframes for publication of a non-binding list of OTC monographs discussed in a 1/27 agency Webinar on monograph reform. Attorney Carolina Wirth (Arnall Golden Gregory) says the agency also needs time to open an OTC monographs Web portal and have it fully operational. “This could be further delayed the longer the agency has to continue putting its resources to address pandemic-related issues,” she writes in an online report.

Wirth says that since FDA and HHS have a new ability to issue interim final orders to address safety issues that could affect entire product lines and categories, “it is now more imperative for companies to closely monitor adverse events so they can anticipate a potential action by FDA.”

She writes that there was no indication in the Webinar of how FDA will prioritize the list of OTC monograph issues, but given all the issues with hand sanitizer products and their high usage during the pandemic, it would make sense that the antimicrobial drugs monograph would be closer to the top of the list.

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