10.Question 10It is the responsibility of Select answerto provide proof that a drug is safe and effective.10 points
Question
10. Question 10
It is the responsibility of Select answer to provide proof that a drug is safe and effective.
10 points
Solution
The responsibility to provide proof that a drug is safe and effective typically lies with pharmaceutical companies and the manufacturers of the drug. These entities are required to conduct rigorous clinical trials and collect the necessary data to demonstrate safety and efficacy. The findings from these trials must then be submitted to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, for review and approval. These regulatory agencies evaluate the submitted evidence before a drug can be marketed and made available to the public. Thus, it is ultimately the pharmaceutical manufacturers who are responsible for providing the proof, with oversight from regulatory bodies.
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