The United States government agency, the Food and Drug Administration (FDA), oversees public health. It focuses on regulating and investigating safety concerns involving the national food supply, medical devices, veterinary drugs, and any product that produces radiation. The FDA also regulates the development and approval of pharmaceuticals.
The drug development process in America begins with discovery and initial development. The phase involves identifying a health issue and developing a potential cure, treatment, or supplement. After organizations develop new product ideas, they undergo extensive preclinical research and laboratory testing, which includes animal testing. Early experiments focus on basic safety fundamentals. Pharmaceutical professionals will initiate clinical trials featuring humans. The process prioritizes safety during the clinical research stage. Developers must also assess the drug's effectiveness and profit margin after the lengthy FDA approval process. Following clinical trials, organizations submit the pharmaceutical projects to the FDA for an official review. The FDA thoroughly examines the product, research, and data. If the FDA approves it, the developers can begin preparations for a product launch. However, the FDA continues to monitor newly released products and may issue a callback or overturn a decision if a product threatens public safety.
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AuthorJeffrey Autrey - Experienced Pharmaceutical Submission Manager. Archives
February 2023
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