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The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience – and what it might mean about regulatory expectations for other chronic drug classes in the future.

Cardiologist William Hiatt, MD (University of Colorado School of Medicine) has a problem with the Food and Drug Administration’s proposal to require cardiovascular outcomes studies for all weight loss drugs, even in the absence of a clear signal of CV risk.

“If you want to impose this requirement on a drug with no signals, I think you ought to impose it...

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In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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