Drugs

OSE Involved in 55 Novel Drug Approvals

The CDER Office of Surveillance and Epidemiology (OSE) 2023 annual report says OSE contributed to 55 novel drug and therapeutic biologic approvals in 2023. The report says OSE staff also were either the signal identifier or safety lead for about 80% of the 206 newly identified safety signals for marketed drugs opened in 2023. “We also played a significant role in increasing access to opioid overdose reversal agents and maintained a steady information exchange with our international regulatory partners on a variety of topics, including artificial intelligence,” the report says.

OSE says it made great strides in its efforts to explore the potential of artificial intelligence and machine learning in its work. “We’ve employed natural language processing for medical chart review, creating gold standard data and scalable computable phenotype algorithms,” it says. “This approach to utilizing electronic health record data and machine learning methods aims to significantly reduce the labor-intensive demands of manual review and to streamline our operations.”

The report also acknowledges the development of the OSE Information Visualization Platform that uses artificial intelligence to enhance post-marketing safety surveillance.

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