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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Removing Gaps in Data Integrity
Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity. If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow. It is used to…
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Hospira Issues A Voluntary Nationwide Recall
On May 4th, 2021, Hospira—a Pfizer company, issued a voluntary nationwide recall to lot DN9185 for potential presence of visible particles. This drug product is a sterile water for injectables and is used to dilute or dissolve drugs for injection. Risks to patients are rare, but could potentially conclude anaphylaxis, fever, gastrointestinal disturbances, vein irritation,…
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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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