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First FDA- Approved Injectable Weight-Loss Drug

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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Moderna applies for full FDA approval of COVID Vaccine

Over 100 million Moderna shots have been administered to patients and just recently, Moderna reached out to the FDA for their full approval. Tuesday, June 1st, Moderna asked the FDA for a full approval of their COVID-19 Vaccine—the second drug producer in the U.S. to seek a biologics license that will allow it to market…
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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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Manual Visual Inspection is Still Critical

Automated visual inspection has been created to perform as an alternative to manual visual inspection.  This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market.  In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better…
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