question archive Food and drug administration department also works with non-governmental organizations, universities and research centers for the development of medical countermeasures for public health emergency preparedness
Food and drug administration department also works with non-governmental organizations, universities and research centers for the development of medical countermeasures for public health emergency preparedness
Subject:BiologyPrice: Bought3
Food and drug administration department also works with non-governmental organizations, universities and research centers for the development of medical countermeasures for public health emergency preparedness. MCM development by applying the condition of ''substantial evidence'' is considered as a major challenge. According to The Federal Food, Drug, and Cosmetic Act (FD&C), any human drug or biological products should be considered as safe to use only if it is demostrated by ''substantial evidence''. Sufficient and controlled examination(well controlled human trials) is called as substantial evidence. It is also considered as unethical when exposing the human volunteers intentionally against the potential threat agent as accidental or natural exposures to threat agents are very uncommon.
"substantial evidence" is a challenge, particularly because it is still subjective and rather vague. It would be more measurable and better understood if the burden of safety was proved with an objective value. However, objective values are difficult to apply across a broad range of MCMs. Do you think "substantial evidence" could be further clarified or objectified?
