FDA Policy/General

Hahn Briefs House Committee on Covid-19 Efforts

FDA commissioner Stephen Hahn 4/22 provided a teleconference briefing to House Energy and Commerce Committee members on the agency’s response to the coronavirus pandemic. “Today’s conversation helps us continue our oversight responsibilities and will inform our ongoing work to address this terrible pandemic,” committee leaders said in a statement after the call.

According to the statement, the bipartisan members discussed a number of issues with Hahn, including:

An update on FDA’s efforts to support Covid-19 vaccine, therapeutics and serological test development;
FDA’s ongoing work with test developers, laboratories and other federal agencies to validate serological tests;
Actions FDA will take to help states acquire the necessary supplies to expand testing capacity;
FDA’s commitment to upholding the agency’s medical product “gold standard” for safety and effectiveness for all medical products to treat Covid-19 and guarantee that science and data lead those decisions; and
The role advanced manufacturing might play moving forward to increase domestic manufacturing, guarantee quality and reduce treatment shortages.

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