Drugs

Rare Disease Clinical Trial Resource Center Proposed

The Rare Disease Clinical Trial Network (RDCRN) funded by the National Institute of Health says there is a need for a Rare Disease Clinical Trial Resource Center that could be leveraged by existing research networks or consortia doing global clinical research in rare diseases. The recommendation is part of the RDCRN response to an FDA request for information and comments on rare disease clinical trial networks.

The RDCRN says it is a research network of 20 rare disease clinical research consortia that are each focused on at least three related rare disorders. It says the intent in establishing a Rare Disease Clinical Trials Resource Center would be to develop a center of excellence to serve as a resource for existing rare disease networks and consortia that will provide the expertise required to design and execute a development program for a new drug, medical device, or biologic that drives efficiency, reduces timelines, and increases the probability of success for getting more treatments to market for rare diseases.

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