What are the requirements for the evaluation of drugs?
In Washington, drugs are subject to evaluation by the state’s Pharmacy Board to ensure that they are safe, effective, and meet standards for quality of use. To begin the evaluation process, manufacturers must submit a New Drug Application (NDA) to the board. The NDA contains information on the drug, including its components, any risks associated with its use, how it is manufactured, and how it is expected to be used. It must also include data from clinical trials conducted to demonstrate the safety and effectiveness of the drug. The board then reviews the NDA, which typically takes several months. The board evaluates the information presented and determines if the drug should be approved. Approval is based on the drug’s safety, effectiveness, and quality. The board may also consider potential side effects, potential risks and benefits of the drug, and the potential for abuse or misuse. Once approved, the drug is subject to ongoing review and monitoring by the board. The board also sets standards for the manufacture and sale of the drug and inspects facilities to ensure compliance. Inspections are conducted to make sure that the drug is safe and of high quality, and to make sure that all necessary precautions have been taken to protect the public. The board may also suspend or revoke approval of a drug if new information is found that suggests it is unsafe or not effective.
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