What are the requirements for the approval of drugs?
In California, drugs must be approved by the US Food and Drug Administration (FDA) in order for them to be available to the public. The FDA has a rigorous approval process in place to ensure the safety and effectiveness of all drugs. The process begins with the manufacturer or sponsor of the drug submitting an Investigational New Drug (IND) application to the FDA. This application must include detailed information about the drug’s composition, production, safety and efficacy, as well as the proposed indications for use. The FDA then assesses the application and decides if the drug is safe to be tested in clinical trials. If the drug is found to be safe, it can then proceed to clinical trials. During these trials, the safety, effectiveness and dosage of the drug are evaluated. Once the clinical trials are successful and the FDA deems the drug to be safe and effective, the manufacturer or sponsor of the drug can then submit a New Drug Application (NDA) to the FDA. This application must include detailed information on the composition, production, safety and efficacy of the drug, as well as the proposed indications for use. The FDA then assesses the NDA and can approve the drug for sale if it finds that the drug meets all the necessary safety and efficacy requirements. Pharmaceutical drugs are then subject to regular post-marketing review by the FDA to ensure their safety and efficacy for continued use.
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