Drugs

FDA Grant to C-Path for Neonate Drug Study

FDA has awarded a multi-year grant to the Critical Path Institute (C-Path) to advance standards and methodologies designed to generate real-world evidence from real-world drug data through a neonatal pilot project by the International Neonatal Consortium (INC). C-Path says the grant will support the collection of neonatal intensive care unit data from many key stakeholders worldwide. The data will be deposited into a real-world data and analytics platform and used to define actionable reference ranges of commonly used laboratory values in neonates and the creation of a natural history model of bronchopulmonary dysplasia, C-Path says.

FDA collaborated with C-Path in 2015 to create the INC to share and standardize data and methods to advance actionable medical product development tools for endorsement by FDA and other global regulatory agencies. The C-Path statement says the INC and its expert stakeholders have developed some influential statements about aspects of neonatal drug development, covering the design and conduct of clinical pharmacology studies, safety assessment, seizures, long-term follow-up, as well as lung, eye, and intestinal conditions unique to children born prematurely.

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