Drugs

FDA Pediatric ECG Warehouse Helps Product Development

Building on the success of its electrocardiogram (ECG) data warehouse that supports FDA’s cardiac safety review of therapeutic product development programs, the agency has created a first-of-its-kind pediatric ECG data warehouse. The warehoused ECGs will be analyzed in pediatric product development programs to help prevent sudden cardiac death in the young (SCDY).

An agency online post says FDA staff partnered with Duke University and multiple medical industry members to secure ECGs from public screening groups (primarily parent-led foundations).

Due to the variability of methods and the ranges of data obtained by the study groups, the warehouse staff developed a core set of essential data elements to promote uniform practices. They also created a universal scannable form, in electronic and paper format, to enable direct digital transfer to the data warehouse through software processing of form images.

Study groups have provided almost 40,000 ECGs to the pediatric warehouse to date, the post says. FDA says the warehouse “promises significant public health advances, including the elaboration of clinical guidelines for assessing risk in children, including risk for SCDY; better pre- and post-market cardiac safety evaluation in children; and the development of biomarkers for use in pediatric clinical trials.”

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