Biotechnology and Biologic Products Regulation: Food and Drug Law Book 6 of 12

The dire necessity for vaccine therapies became apparent with the COVID-19 pandemic that commenced in early 2020. Initially, former FDA Commissioner Hahn emphasized at the time of the pandemic there were no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are now approved and authorized vaccines to combat this virus as well as treatments such as Remdesivir, an antiviral drug used for Ebola manufactured by Gilead Sciences, Inc. which was approved to treat...