Drugs

MDIC Issues Landscape Analysis Report

The Medical Device Information Consortium (MDIC) has released a landscape analysis report created from work conducted by its somatic reference sample (SRS) initiative. The report says the subgroup was charged with conducting a thorough analysis of projects related to NGS (next-generation sequencing) reference samples to (1) avoid duplicative efforts; (2) identify gaps where the desired optimum reference samples are not yet developed or available; and (3) help define specific gaps and unmet needs with respect to, for example, sample type(s), genes, variants, etc.

MDIC says the sub-group has multiple stakeholders including reference sample manufacturers, regulatory agencies, validation study leaders, and end users of reference samples who contributed to this comprehensive summary identifying other efforts for development and evaluation of NGS reference samples that may inform and complement the SRS goals.

“The report is intended for the use of the diagnostic testing community for a variety of applications, including (but not limited to) assay development, test validation, and quality control,” MDIC says.

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