Drugs

FDA Covid Global Partnering Explained

An online post explains how FDA is building on its more than a decade of experience in working with the European Commission and its European Medicines Agency (EMA) to collaborate on several scientific and regulatory fronts as part of the Covid-19 response. The paper says that what has helped drive the Covid collaboration are the 30 technical expert groups, known as clusters, that FDA and EMA have established since 2003.

“These clusters meet regularly for discussions held under confidentiality commitments and were well-positioned to pivot to focus on Covid-19 because of our ongoing work together,” write FDA deputy commissioner for policy, legislation, and international affairs Anna Abram and associate commissioner for global policy and strategy Mark Abdoo. “In these expert group discussions, FDA and EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions.”

The paper also says that FDA is leveraging inspection reports completed by the European Union (EU) and the UK under the pharmaceutical annex to the US-EU mutual recognition agreement.

“We are also leveraging our international collaborations in our medical device work,” the paper says. “FDA and global partners regularly exchange information on medical device safety issues and regulatory developments.”

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