Drugs

EdjAnalytics’ Predictive Inspection Model for FDA

Under a contract with CDER, EdjAnalytics, a data science firm providing artificial intelligence, machine learning and advanced analytics for life sciences, has developed a predictive model to support the agency’s decision-making process to select manufacturing sites for inspection. “The model provides the likelihood of a facility having an inspection outcome of an OAI (Official Action Indicated), VAI (Voluntary Action Indicated) or NAI (No Action Indicated),” Edj says. “Additionally, the model produces information about what factors most influence a particular outcome.”

Edj began working on the inspection model 9/2018. “After completing the modeling earlier this month, Edj is currently working to assist the FDA in integrating the results of its analysis,” it says. Under the contract, Edj says it “trained machine learning models on historical inspection outcomes to create a predictive model. Features related to facilities, their associated products and their historical inspection outcomes were used as model inputs. Model development was guided by predictive error, implementation feasibility and the interpretability of findings to stakeholders.”

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