Devices

FDA Recognizes Genetic Public Database

FDA says it has formally recognized the genetic variant information in the Clinical Genome Resource consortium’s ClinGen Expert Curated Human Genetic Data database as a source of valid scientific evidence that can be used to support clinical validity in premarket submissions. FDA says this is a significant step forward in driving efficient development of novel diagnostic technologies that scan a person’s DNA to diagnose genetic diseases and guide medical treatments.

An agency news release says the information in the open database has been collected and studied by researchers across the world. Recognition by FDA will facilitate test developers, including those who use next generation sequencing, to rely on the information available in the database to support the validity of their tests, instead of having to generate the information on their own.

The release says that the recognition means that developers will not need to demonstrate to the agency the reliability of the database, the data, and information within that can be used to support the relationship between a gene variation and a specific disease that are within the scope of agency regulations. For example, it says, the sponsor of a test that detects variants involved in hereditary cardiomyopathy could point to the cardiomyopathy genetic variant information available in ClinGen as part of a submission to support clinical validity of their test.

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