https://news.yahoo.com/fda-allows-emergency-drug-coronavirus-195025339.html
"The FDA said preliminary results from the government study warranted Friday's decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”The drug's side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.The National Institutes of Health’s Dr. Anthony Fauci said Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. Remdesivir, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.The FDA authorized the drug under its emergency powers to quickly speed the availability of experimental drugs, tests and other medical products during public health crises.In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards and require only that an experimental treatment's potential benefits outweigh its risks.Gilead has said it will donate its currently available stock of the drug and is ramping up production to make more. It said the U.S. government would coordinate distribution of remdesivir to parts of the country that need it most."
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