Drugs

CTTI Releases Real-World Evidence Meeting Summary

The Clinical Trials Transformation Initiative has released a one-page summary of a 6/2018 expert meeting it convened to discuss best practices and needed resources for advancing use of real-world evidence in randomized clinical trials. The meeting included investigators, patients, regulators, technology experts, sponsor representatives, and other groups, CTTI says.

“While participants agreed that the use of real-world evidence could be a major step forward in clinical trials,” CTTI says, “they stressed the importance of recognizing and planning for its limitations, including inconsistent data reliability and quality. They also agreed that direct interaction with participants and the integration of various real-world data sources are critical for improving the depth and breadth of available date. As a next step in its real-world evidence work, CTTI will develop recommendations and resources for incorporating [it] into randomized trials for regulatory submission.”

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