Final answer:
The Center for Drug Evaluation and Research (CDER) is responsible for overseeing the drug approval process in the United States, from initial application through clinical trials to ensuring that new drugs meet safety and efficacy criteria.
Step-by-step explanation:
The Role of CDER in Drug Approval Process in America
The Center for Drug Evaluation and Research (CDER) is a critical branch of the U.S. Food and Drug Administration (FDA) that oversees the drug approval process in America. After a drug is discovered or synthesized, developed and tested by a chemist for toxicity and efficacy, the process of approval for human use starts with an Investigational New Drug (IND) application to CDER. Following a 30-day review period wherein the FDA examines the IND, clinical trials on humans may proceed, unless a clinical hold is issued to address any raised concerns. Researchers collect and analyze efficacy and safety data, including side effects. If the drug demonstrates safety and effectiveness, developers submit a New Drug Application (NDA), which includes details on manufacturing, packaging, monitoring, and administration criteria. CDER's requirements for drug approval particularly focus on verifying that new drugs are safe and effective for intended use.