USA utökar nödtillståndet för remdesivir

An emergency use authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.After initial authorizations for serious diseases such as pandemic influenza and emerging diseases, EUA's were also authorized for medical countermeasures (MCM's) principally in response to public health emergencies such as bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats. Subsequent legislative authorities expanded the latitude of the class of drugs eligible for consideration, and the range of testing to which the drug or therapy has been subjected. The scope and applicability of EUA's is also affected by presidential executive orders (Title 3 of the Code of Federal Regulations), which may affect the definition of the situations considered to be public health emergencies, and under which the authority of the FDA to issue EUA's may be exercised. Consideration of a drug for an EUA requires a finding that it is "reasonable to believe" that the drug "may be effective" "to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a [chemical, biological, radiological, and nuclear] agent(s)" or to mitigate a disease or condition caused by an FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals, using a risk-benefit analysis based on "the totality of the scientific evidence available", it is "reasonable to believe" that the product may be effective for the specified use.EUAs end once the Secretary of Heath and Human Services determines that the precipitating emergency has ended (in consultation with the issuer of the appropriate state of emergency as necessary), or once the product or unapproved use is approved through normal channels.