Devices

ACRO Says More Wearable Technology Coming

The Association of Clinical Research Organizations (ACRO) says that a survey indicates a coming rapid increase in use of wearable technology and an upsurge in social media for patient recruitment. “ACRO members are at the forefront of developing and implementing new clinical trial technologies to enhance efficiency and improve the patient experience,” says ACRO senior vice president for policy and public affairs John Lewis. “But the biopharmaceutical industry is heavily regulated so there are several areas where we are requesting that FDA consult with stakeholders and provide additional guidance to encourage the adoption of these exciting technologies. We thank FDA for requesting input on this issue.”

Other areas in which ACRO members identified substantial benefit/increase in adoption include risk-based monitoring, electronic informed consent, and the use of near real-time trial data analytics. Lewis said that FDA has already provided guidance on risk-based monitoring and electronic consent and the industry has been actively implementing those tools and technologies.

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

Read more

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