Quality

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‘Serious Quality Problems’ at Eli Lilly Production Facility Used to Produce POTUS Touted Monoclonal Antibodies

The U.S. Food and Drug Administration (FDA), not the clinical sponsor, paused a recent study based on serious quality control issues at a production facility of Eli Lilly and Co. Apparently, this plant represented one of the facilities the company was preparing to...

FDA Halting Fecal Matter Transplant Studies to Ensure Proper Procedures in Place Post Serious Adverse Event including a Death

The U.S. Food and Drug Administration (FDA) has issued a safety alert for fecal transplant procedures after two immune-compromised patients contracted drug-resistant infections. The patients received transplants from the same donor, and one of the patients died....

Why have up to 150 Deaths at Heart Unit of St. George’s Hospital South London occurred in the past 5 years?

Site Watch—Concerns: Why have up to 150 Deaths at Heart Unit of St. George’s Hospital South London occurred in the past 5 years? This is a horrifying number of deaths in today’s day and age. TrialSite News notes that St. George’s Hospital is a research site for dozens...

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