Drugs

FDA Developing Ways to Predict Drug Effects Before Trials

CDER researchers are developing microengineered human cellular systems that allow for replication of human physiology and better prediction of drug effects before clinical trials are started. An agency Regulatory Science Impact Story says limitations in detecting drug toxicity before clinical trials means that drug developers often conduct costly trials of new drug compounds only to have them fail when toxic effects are observed.

“Through a variety of projects,” the report says, “the Integrated Cellular Systems Laboratory in CDER’s Division of Applied Regulatory Science is studying how to use physiological cellular microsystems to advance drug development. Because hepatic and cardiac toxicities account for most of the unanticipated side effects of candidate drugs, CDER researchers are focusing on systems to advance our ability to model drugs’ effects on the liver and heart.”

The report says the platforms will be especially useful in contexts where clinical trials are limited or not feasible, such as efforts to develop medical countermeasures to public health emergencies and to evaluate therapies to treat rare diseases.

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