Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the usual routine of online meetings, phone calls and deadlines has returned. You knew this would happen, yes? So to cope, we are firing up the coffee kettle and brewing cups of stimulation. Our choice today is the ever-delightful cinnamon dolce. Please feel free to join us. Or grab a bottle of water, if you prefer. Meanwhile, we have assembled the latest line-up of interesting items for you to peruse. We hope your journey today is meaningful and productive. And as always, please keep in touch. Your tips and insights help the world go around…
Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a U.S. Food and Drug Administration inspection report obtained by STAT. During a recent visit to the facility in Tamil Nadu, India, agency inspectors found the company failed to take basic steps during sterilization, relied on deficient manufacturing processes and methods to ensure and verify sterility, and lacked adequate systems to create aseptic conditions. The FDA inspected the plant in several weeks ago, shortly after the company began recalling its eye drops over concerns about contamination.
The U.S. National Institute on Aging is funding a six-year, up to $300 million project to build a massive Alzheimer’s research database to track the health of Americans for decades and enable researchers to gain new insights into the disease, Reuters reports. The NIA aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population. The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and government agencies. Real-world data is needed to make decisions about the effectiveness of medications and looking at broader populations than most clinical trials can cover, an NIA official said.
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