Devices

FDA Should Develop Vision PRO Tool: AdvaMed

The Advanced Medical Technology Association (AdvaMed) is urging FDA to proceed with stakeholder recommendations to develop a “central item bank or horizontal PRO [patient-reported outcomes]” tool for all vision disease states in clinical trials. AdvaMed’s comments were submitted to the docket of a 9/29 FDA virtual public workshop entitled “Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires.”

“Given FDA’s push towards utilizing PROs as an input to regulatory decision-making, we believe such an approach could be beneficial to advancing innovation,” AdvaMed said. “Industry would be interested in leveraging such a tool in clinical datasets as part of marketing authorizations.”

AdvaMed supported workshop participants and their discussions on the benefits of gaining greater insights and information about patient experience with ophthalmic devices and procedures through the use of PROs. “PROs can help inform technological advances as well as regulatory decision-making,” the group said, adding that PRO instruments can also be challenging and resource-intensive (costly) to develop.

“From a company perspective, the development of PRO instruments continues to be a burdensome, costly and lengthy process which has the potential to limit innovation in the ophthalmic space,” AdvaMed told the agency. “The significant costs, the extensive development time which can be longer than the device development timeframe, and the uncertainty of whether the PRO will be accepted by FDA after sponsor investments of significant time and resources, meaningfully discourage interest in and investment in PRO instruments.” All of these hurdles point to having FDA lead the development of the PRO tools to eliminate some of the perceived burden and uncertainty, AdvaMed said.

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