Drugs

Quantitative Medicine Innovation Network RFI

FDA has issued a Request for Information (RFI) seeking feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high-priority areas through the application of Quantitative Medicine (QM) approaches, and exploring mechanisms to leverage community expertise and capacity to promote QM innovation and adoption. The agency will accept comments on the RFI until 11/3.

The notice says CDER’s Quantitative Medicine Center of Excellence will use the submitted information to inform the development and implementation of a cross-sector innovation network. The proposed mission of the network is to connect agency scientists, academia, healthcare providers, patient groups, and other regulatory partners in driving the development and implementation of QM to tackle critical unmet needs of the community by fundamentally transforming drug development and clinical care.

Specific areas in which the FDA wants information include the project scope, operating model, and priority cases.

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