What are the requirements for the evaluation of drugs?
In California, all drugs must undergo an evaluation process before they can be legally prescribed or distributed by pharmacies. The evaluation process begins with the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA). The NDA must include information about the drug’s ingredients, its effects, and its safety and efficacy. Once the NDA is received, FDA representatives review both the safety and efficacy of the drug, and analyze the risk of side effects. The drug’s safety is evaluated using animal and clinical trials. Animal trials are conducted on different species of animals to determine the drug’s potential toxicity. Clinical trials are conducted with humans to study the drug’s effects, how it interacts with other drugs, and how the body metabolizes it. The FDA also evaluates the drug’s efficacy, which is its ability to produce the desired effect in humans. The efficacy of the drug is assessed by comparing its effects to those of a placebo. In addition, the drug’s effectiveness is evaluated through patient surveys and questionnaires. When the evaluation process is complete, the FDA will decide whether or not the drug is safe and effective for human use. If the drug meets the necessary standards, it will approve the drug for distribution. Only then may the drug be legally prescribed or distributed by pharmacies in California.
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