Drugs

CDER Researches Convolutional Neural Networks

CDER researchers are working on applying artificial intelligence/machine learning in the form of convolutional neural networks (CNNs) to enable the processing of large collections of images with high efficiency and accuracy by distinguishing complex “textual features” that are not readily delineated with existing image processing software. An online report describes a case study in which CDER researchers and collaborators at Ursa Analytics, the University of Colorado, and the National Institute of Standards and Technology implemented CNNs to further the understanding of certain product quality attributes for a model therapeutic protein formulation.

“The study demonstrated the advances in microscopy analyses and a tool to monitor changes in product quality attributes can be achieved through CNN-based approaches, and the study’s findings may be applicable to evaluation of a variety of biopharmaceutical drug products,” the report says.

CDER says the methodology applied in the study is applicable to a range of products in pharmaceuticals and biopharmaceuticals to monitor changes in product attributes such as particles/aggregates during manufacturing. “The analytical procedure (flow microscopy combined with CNN image analysis) explored in the CDER research study can detect small shifts in protein aggregate populations due to stresses resulting from unknown process upsets providing potential new strategies for monitoring product quality attributes,” the report says. “In addition, use of a reference standard such as ethylene tetrafluoroethylene that is stable over time and possesses optical properties similar to those of protein aggregates is useful for validating and evaluating the robustness of the analytical procedure.”

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