Drugs

FDA Describes New QSAR Model

An FDA online post describes the work done by agency researchers in the Division of Applied Regulatory Science to develop a new quantitative structure-activity relationship (QSAR) model to predict blood-brain barrier permeability. The post says two statistical-based QSAR models were developed to predict drug permeability across the blood-brain barrier.

“The intended purpose of these models is to assist regulators with abuse liability assessment of drug metabolites or other materials related to drug substances,” the post says. “Furthermore, these models can be used to predict whether an unknown substance of abuse can permeate the blood-brain barrier to produce effects predicted by the Public Health Assessment via Structural Evaluation (PHASE) approach. PHASE is a multi-component computational approach that determines if newly emerging drug substances on the street-drug market are a risk to public safety.”

The post says the identification of drug candidates or other substances in the finished drug product that cross the blood-brain barrier can inform strategies for reducing the potential for abuse liability in a regulatory setting and can assist drug developers with designing drugs intended to act on targets in the central nervous system.

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