Devices

FDA Agrees with Consultants on Covid Test EUAs

FDA says it agrees with priority recommendations made by Booz Allen Hamilton in an independent assessment of the CDRH Covid-19 response in terms of emergency use authorization (EUA) of Covid-19 tests. For its work, Booz Allen Hamilton reviewed primary documents and conducted internal and external stakeholder interviews to evaluate FDA’s response and recommend improvements, an FDA announcement says.

The consultant report contains these priority recommendations that FDA consider:

ways to optimize the information technology system to account for EUA processes, since precise tracking of new review metrics was encumbered by the IT system;
developing a systematic approach (strategy and plan) for allocating and tracking staff during public health emergencies, since it was difficult to determine what events or criteria triggered shifts in staff and how shifts were coordinated to address the triggering event or criteria; and
developing a framework for how to conduct validation of diagnostic tests for emerging pathogens in the setting of a declared public health emergency, since there was limited understanding in the test development community of how to appropriately validate a diagnostic test.

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