Devices

Workshop on DNA-based Cancer Screening Tests

FDA has announced a 3/9 workshop on “Detecting Circulating Tumor DNA for Cancer Screening.” The workshop will discuss the appropriate study designs needed to demonstrate the safety and effectiveness of cancer screening tests and to support cancer screening claims. It will also discuss the clinical, scientific, and regulatory challenges associated with developing circulating tumor DNA-based (ctDNA) cancer screening tests.

FDA says that recent advances in the technology to isolate ctDNA from blood samples, in addition to advances in the ability to detect unique cancer-specific variants, have fueled the development of cancer screening tests using ctDNA in asymptomatic subjects. Several clinical and scientific challenges are associated with the screening tests, including the “ideal clinical study design to determine the requisite level of sensitivity and specificity for these tests and the data needed to assess whether the benefits of such tests outweigh the risks,” the agency says.

To learn more about the workshop, click here.

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