FDA Drug Approval Process

The FDA approval process for drugs involves several steps to ensure safety and effectiveness. First, researchers conduct laboratory and animal studies. Next, they submit an Investigational New Drug application to start human clinical trials, which occur in three phases to test safety, dosage, and efficacy. If trials show positive results, the company files a New Drug Application (NDA) with detailed data. The FDA reviews this information thoroughly, evaluates benefits versus risks, and inspects manufacturing facilities. If the drug meets standards, the FDA approves it for public use. This process helps ensure medications are safe and effective before reaching patients.