Devices

Sequencing Guidance Raises Questions: Attorney

Attorney Gail Javitt (DLA Piper) says that a recent FDA draft guidance on agency oversight of certain applications of next generation sequencing (NGS)-based technology leaves several threshold questions unanswered. Writing in an online post, Javitt says that the standards proposed in the guidance address areas including test design considerations, test performance characteristics, performance evaluation, variant annotation and filtering, and test reports.

Questions that remain unanswered, it says, include:

Which tests will be subject to the recommendations?
To what entities will the recommended standards apply, for example, instrument developers, clinical laboratories, algorithm developers?
Is the guidance scope actually limited to analytical validity considerations, as FDA says, or does it actually encompass the clinical validity of using test results in a patient treatment context?
Will FDA require premarket review for NGS-based tests and if so, what type of review and approval?

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