Drugs

FDA to Extend Comment Period on Rx Software Notice

FDA says that after the partial government shutdown ends it will extend or reopen the comment period on an 11/20/2018 Federal Register notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments” (Docket No. FDA-2018-N-3017). In the notice, FDA is seeking comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. The proposed framework would provide prescription drug sponsors the flexibility to develop and disseminate innovative software, while maintaining appropriate agency oversight over the sponsors’ communications about their products. Software that is developed for use with prescription drugs but is not disseminated by or on behalf of a drug sponsor is not addressed in the proposal. Last month, Pharmaceutical Research and Manufacturers of America requested a comment period extension. To view the original notice, click here.

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