Drugs

CURE ID Updated for Better Covid Use

FDA and the National Center for Advancing Translational Sciences at the National Institutes of Health say they have updated the CURE ID app to make it a more effective tool during the Covid-19 public health emergency. A joint statement describes CURE ID as an Internet-based repository that allows clinicians to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs through a Web site, smartphone, or another mobile device. Clinicians also can access cases entered by other users and view them as individual case reports or an aggregated dataset, the agencies say.

The updates will allow clinicians to more easily report their experiences treating Covid-19 patients, with either positive or negative treatment outcomes, who are unable to be enrolled in a clinical trial, the notice says.

“The full case report form remains highly focused and can be completed in a few minutes,” the post says. “It can be entered by any staff member with access to the patient’s medical records. The goal of the case reporting is to generate hypotheses to be further studied in randomized clinical trials.”

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