Drugs

Sequencing Regulatory Pathway ‘Helpful’: Comment

The Critical Path to TB Drug Regimens says that an FDA draft guidance on infectious disease next generation sequencing laying out a regulatory pathway that better defines the regulatory requirements for next generation sequencing (NGS) will be helpful to those developing diagnostic devices for antimicrobial resistance, and tuberculosis in particular. Commenting on the draft guidance, the group says the regulatory-grade reference database requirements for microbial identification and antimicrobial resistance are undefined and quite different. “It would be helpful to separate these two concepts,” it says, “regarding the regulatory-grade reference database.” The letter also asks for clarification of whether the guidance would also apply to a device that can detect multiple microbial pathogens, and asks for a section devoted to targeted sequencing.

Roche’s response appreciates the “innovative and flexible regulatory framework that FDA has outlined for the regulation of NGS devices” in this guidance and other forums. The company suggests that the approaches the agency is following for the regulation of NGS devices could and should be applied to other in vitro diagnostic technologies. And it says that FDA should follow precedent and expressed policy focused on NGS tests rather than taking a systems approach to review.

In its comment, AstraZeneca says that the guidance’s definition and clarity on the “one system” approach are very welcome and provide clarity on the scope of what needs to be regulated. “This appears consistent with other guidance but will prove burdensome,” it declares. “Are there any opportunities to consider ‘modular’ approvals in order to facilitate a ‘mix and match’ approach? For example, could the specimen collection module be approved and applied to other relevant processes without duplicating the review? Could this be applied to other modules such as sample preparation or sequencing chemistry/data collection? If so, how could the approval of such modules be shared so as to avoid unnecessary duplication of experimental work and FDA review activity?”

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