Drugs

Pilot on Innovative Drug Development Tools

FDA is detailing the launch of a new pilot program to provide a pathway for novel drug development tools (DDTs) to be used in regulatory applications for new medical products. The program, Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program, is intended to streamline and potentially speed up new drug and biologic development. “For instance, the scientific community is making great strides with artificial intelligence and microphysiological models — which are miniature models of human organs or connected systems,” an agency post says. “These both could be types of DDTs that lead to rapid advances in developing new drugs,” it says.

The plan is to evaluate novel DDTs similar to how FDA currently evaluates biomarkers and clinical outcome assessments, but with more feedback from the agency when needed. Some examples FDA would consider under the pilot include:

Data collection or analysis methods that differ from current standard approaches
Tissue chips, which are miniature models of human organs, for safety assessments
Certain digital health technologies, including artificial intelligence or wearable sensors, used during clinical trials

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