FDA Policy/General

FDA Opening Office in Rwanda

FDA is opening an office in the U.S. embassy in Kigali, Rwanda, to provide direct support to the African Medicines Agency (AMA). Announcement of the office was made by FDA associate commissioner for global policy and strategy Mark Abdoo on 6/26 in a presentation at the 2024 Global Health Regulatory Team Convening in Kigali. Part of Abdoo’s presentation involved a discussion of the agency’s efforts in Africa.

“I would like to express FDA’s strong commitment to support the operationalization and long-term success of the African Medicines Agency,” Abdoo said. “We are all eager to see the AMA become active. As that time comes, I would like to recognize the remarkable depth and breadth of technical capacity and regulatory infrastructure that has been developed by many of you under African Medicines Regulatory Harmonization and elsewhere. The products of your ongoing hard work will truly benefit the AMA.”

In his presentation, Abdoo also discussed some of the challenges faced in the global marketplace for medical products such as supply chain complexity, medical product shortage, and quality issues. He also gave an overview of some of FDA’s global work.

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