The drug approval process typically involves several key stages:
1. Preclinical Testing: Before human trials, extensive laboratory and animal tests are conducted to assess the drug’s safety and efficacy. 2. Clinical Trials: These trials are divided into phases (Phase I, II, III) to test the drug on human subjects to further evaluate its safety and effectiveness. 3. New Drug Application (NDA): After successful clinical trials, a company submits an NDA to the regulatory body, including all data from preclinical and clinical tests. 4. Review and Approval: The regulatory agency reviews the NDA, which involves a thorough examination of all submitted data, and may request additional information or tests. 5. Post-Marketing Surveillance: Even after approval, the drug is monitored for any long-term or rare side effects.