Traditional Culture Encyclopedia - Traditional festivals - What ethical decision-making and review should be undertaken by the FDA in the process of vaccine development
What ethical decision-making and review should be undertaken by the FDA in the process of vaccine development
2, human trials: FDA should review and supervise the human trials of vaccines to ensure that the trials comply with ethical principles and laws and regulations, and to ensure the safety and effectiveness of the trials, information disclosure: FDA should ensure that the vaccine-related information is open and transparent, including vaccine composition, dosage, manufacturing process, storage and transportation conditions, safety and efficacy of the information.
3. Risk management: FDA shall assess and manage the risks of vaccines, including the assessment and management of adverse reactions, side effects, allergic reactions, etc. that may be caused by vaccines.
4, emergency use authorization: In an emergency, the FDA can authorize the emergency use of vaccines, but need to ensure the safety and effectiveness of the vaccine, and the use of supervision and management.
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