FDA Policy/General

FDA Plans New Project for Emerging Genomics Technologies

FDA is developing a new genomics project called Sequencing Quality Control Phase 2 (SEQC2) that aims to develop quality control metrics and benchmark bioinformatics approaches for analyzing whole genome sequencing and targeted gene sequencing data. The project is also designed to achieve best practices, to develop standard analysis protocols, and to apply these newer methods in regulatory settings related to next-generation sequencing (NGS), according to agency officials writing in the AAPS Journal. “The ultimate goal of SEQC2 is the development of standards for using NGS data that will provide the FDA with objective criteria and metrics for data quality assessment that can be applied in regulatory settings and to provide information for precision medicine,” they say.

In their article, the officials also examine previous work under the MicroArray Quality Control (MAQC) consortiumm which was led by the agency to analyze the technical performance and utility of emerging molecular technologies for clinical applications and safety assessments. The primary aim of these FDA-led efforts for emerging genomics technologies “is to engage the stakeholders and research community for consensus building with respect to the reliable use of genomics data with objective criteria and assessment metrics for data quality and reliability, which can be employed in the FDA for their fit-for-purpose application,” they say.

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