Drugs

Feedback Sought on Integrated Review Document

FDA is seeking comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, original BLAs, and select efficacy supplements. An agency notice says the comments should focus on the characteristics of the Integrated Review and specifically address the following:

Comparing the Integrated Review to previous review documentation, is there any information stakeholders are having difficulty locating? Are stakeholders able to use the Integrated Review for the same purpose previous review documents allowed?
Areas of the Integrated Review documentation that can be improved to meet stakeholder needs.
The advantages and disadvantages of an interdisciplinary assessment presentation of key review issues and the integration of the assessments of multiple disciplines into a single Integrated Review document.
Clarity of benefit-risk assessments in the Integrated Review.
Are the issues that concerned the review team clear and understandable in the Integrated Review, and how can this be improved?

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