What is the role of the FDA's Center for Drug Evaluation and Research (CDER)?

The role of the FDA's Center for Drug Evaluation and Research (CDER) is primarily focused on reviewing new drugs for safety and effectiveness. CDER evaluates investigational new drugs before they can be marketed to the public, ensuring that they are both safe for use and effective in treating the intended conditions. This involves a thorough review process that examines clinical trial data, manufacturing processes, product labeling, and compliance with regulatory standards.

Understanding this role is critical because it forms the foundation of how drugs enter the market and assures the public that treatments have met rigorous scientific evaluation. CDER's responsibilities extend beyond just initial approval; the center also monitors drugs post-approval to ensure ongoing safety and effectiveness through processes such as risk management and adverse event reporting.

Other options reflect different aspects of the FDA's overall function but do not pertain specifically to CDER's primary mission. For instance, medical devices are primarily overseen by another FDA center, clinical trials are designed and managed by sponsors rather than a regulatory body, and drug pricing strategies are generally not managed directly by the FDA. Thus, the focus on review and approval of new drugs for safety and effectiveness distinctly highlights the core function of CDER within the FDA.