Devices

FDA Looks for Coronavirus Test Info on Twitter

Unable to require medical device manufacturers to report shortages, FDA is turning to Twitter to hunt for information on coronavirus testing supplies. Politico reports that a “fundamental gap in the flow of information has made it impossible for FDA to identify weaknesses in the supply chain for coronavirus testing and in the nationwide push to test hundreds of thousands of patients…. So FDA is making plaintive appeals on Twitter, in addition to negotiating with companies behind the scenes.”

A 3/17 tweet from FDA deputy commissioner for medical and scientific affairs Anand Shah suggested that companies make public their inventory, production schedule, and a hotline number to address questions about the availability of reagents and other supplies needed for Covid-19 testing. A subsequent Shah tweet said FDA wants information about swabs, test kits, instruments, and supplies for transporting and preparing samples for analysis.

A spokesperson for AdvaMed said the trade association is working with FDA to find the best way to ensure that appropriate information gets to the agency.

Politico says the president’s 2020 budget request proposed requiring medical device makers to tell FDA if a significant interruption of essential products was likely, and to file reports on their manufacturing capacity. There also are bills in Congress to accomplish the same goal.

“But with those proposals in legislative limbo,” the article says, “the agency may have to get creative to track potential shortages at a time when countries around the world are competing for the same basic testing supplies.”

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