FDA Policy/General

Docs Should Reassure Covid Patients About FDA: Hahn

FDA commissioner Stephen Hahn told an 8/10 teleconference of doctors and other healthcare professionals that the agency needs their help in communicating to patients that all FDA Covid-19 decisions are based on science. “I want to reassure you that the decisions that FDA will have to make in the coming months with regard to new tests for Covid-19, new therapeutics, and new vaccines will be based on good science and sound data,” Hahn declared.

He said that because of the speed at which the agency is working, there have been concerns voiced that it might compromise its scientific principles in reviewing data and approving new products. “Let me assure you that we will not cut corners,” he said. “All of our decisions will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products. It is important that you as medical practitioners not only understand this commitment but also that you reassure your patients.”

In the interest of openness and transparency, Hahn reviewed the emergency use authorization (EUA) decisions during the pandemic involving early tests that proved ineffective and the anti-malaria drugs chloroquine and hydroxychloroquine that FDA first authorized for use in specific situations and later withdrew the EUA.

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