Influenza Research 2022

Laws and Ethical Issues Related to Flu Research

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The Secretary of the Department of Health and Human Services has responsibility for preventing the introduction, transmission, and spread of communicable diseases in the United States. In IPR studies patent applications covering the virus itself, vaccines, treatment and diagnostics. Clinical studies of influenza involves development of drugs for the treatment  and/or prophylaxis of illness caused by influenz a viruses A and B, including both seasonal and  pandemic varieties. Sponsors considering development of antiviral drugs for the treatment or prophylaxis of disease with novel influenza strains, or in a pandemic influenza setting, are encouraged to consult this guidance and to communicate with the FDA through the pre-investigational new drug application (pre-IND) consultation program and frequently throughout drug development.