Obesity researches just created a ‘Game-Changer’ weight loss drug that has been approved by the FDA. This is the first FDA-approved weight-loss drug since 2014. This drug is not an entirely new medication; it has been used in the US and other countries as an anti-diabetic medication. In research, it has shown that this drug—semaglutide—has…
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What is a Recall?
About 4,500 drugs and devices are recalled yearly in the United States. Prior to these recalls, they were approved by the FDA, widely injected, implanted and ingested by customers. The FDA does not initiate a recall, they simply express concern and leave it up to the manufacture to execute a recall. The FDA can only…
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The Importance of Data Integrity
On January 15, 2021, GMP Trends posted Issue #1056. In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years. For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked…
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