What are the requirements for the approval of drugs?

In Maryland, the approval of medications is subject to regulations that are overseen by the United States Food and Drug Administration (FDA). In order for a medication to be approved, it must go through a series of tests and studies in order to demonstrate that it is safe and effective. Before a medication can be considered for approval, it must undergo a rigorous pre-clinical phase which involves testing the medication in laboratory experiments and animal trials. This phase will provide the FDA with important safety and efficacy information on how the medication will act in the human body. Once the pre-clinical phase is complete, the medication can then proceed to clinical trials with human participants. These trials are divided into three phases: Phase I, II, and III. During these phases, the medication is tested on increasing numbers of people in order to determine its safety and effectiveness. Once the clinical trials are completed, the FDA will then assess all of the data from the trials and will decide if the medication is safe and effective enough to be approved for sale. The FDA may also require additional testing before making their final decision. If they decide to approve the medication, the drug manufacturer must then submit a New Drug Application to the FDA in order for the medication to be legally sold in the United States. In summary, the approval of drugs in Maryland requires a comprehensive pre-clinical and clinical trial process along with an approval from the FDA. The FDA will only approve drugs that have demonstrated their safety and effectiveness in clinical trials.

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What are the requirements for the approval of drugs?

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