Drugs

CDER Launches Trial Innovation Center

CDER is announcing the launch of its Center for Clinical Trial Innovation (C3TI), which the Center says is intended to promote clinical trial innovation activities through enhanced communication and collaboration. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development,” a Center notice says. “C3TI will facilitate the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives and will communicate and collaborate with external parties. C3TI will also manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further implementation.” The main three focus areas are (1) point-of-care or pragmatic trials; (2) Bayesian analyses; and (3) trials using selective safety data collection.

C3TI is also intended to benefit both internal and external stakeholders by providing access to information on clinical trial innovation efforts more easily, engaging in collaborations, identifying resources that can further support “innovative modalities,” and identifying development programs where clinical trial innovations would be impactful, CDER says. “The goals of these efforts are to assist those involved in clinical research in staying current with clinical trial innovations, improve the efficiency and effectiveness of clinical trials, help increase the participation of diverse populations in clinical trials, and, in turn, accelerate the development of safe and effective new drugs,” it says.

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