Tag Archives: data integrity

Novavax’s COVID-19 Vaccine

Novavax created the fourth COVID-19 vaccine that could be available in the US this year.  This vaccine is reported to be a two-dose regimen and is highly effective out of all other US vaccines during the clinical trial.  Novavax is seeking FDA approval and authorization while in the third quarter of their testing. Novavax is…
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Routes of Drug Administration

The route of drug administration is defined as the path by which a drug is taken into the body.  Drugs are administered varied by diagnosis, prevention, cure or treatment needed of diseases and other medical disorders.  A drug must come in contact with the tissues of organs to achieve its desired effects. The route of…
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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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