FDA Policy/General

Five Covid ‘Learnings’ Will Continue After Emergency: FDA

FDA acting commissioner Janet Woodcock has identified five key activities the agency experienced during the Covid-19 pandemic that will be expanded or continued after the public health emergency has ended. “As we continue our Covid-19 response, it is critical that we learn from both our successes and the challenges we experienced, to best improve our operations,” she says in an agency release. “We seek to improve our effectiveness, efficiency and transparency. This work will strengthen the agency’s public health infrastructure and build the resilience to respond in an emergency.”

Woodcock notes that the five target areas have grown out from a January summary report from an independent third-party review of the agency's pandemic response as part of FDA’s Covid-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative. The five areas are (the first is two recommendations !folded into one):

Reviewing aspects of the emergency use authorization processes for medical products and identifying areas for potential improvement. The objective is to ensure transparency and facilitate the appropriate integration of these products, including diagnostics, therapeutics and vaccines, into medical care.
Reviewing science-based communications to ensure the agency continues to provide timely and accurate communications to the public.
Evaluating inspectional approaches using next-generation assessment technologies, such as virtual and video-enabled platforms, to further FDA’s inspectional reach.
Evaluating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges to help stakeholders improve chain resilience.

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