CDER stands for the Center for Drug Evaluation and Research. It is an important division within the United States Food and Drug Administration (FDA) that is responsible for evaluating prescription and over-the-counter drugs for their safety, efficacy, and quality before they are approved for market distribution.
The CDER plays a crucial role in the drug regulatory process by ensuring that drugs are safe and effective for their intended uses. This involves conducting thorough reviews of clinical trial data, evaluating the manufacturing processes, and inspecting facilities to ensure compliance with FDA regulations. The CDER also acts as a resource for healthcare professionals and the public, providing information and guidance on drug labeling, adverse event reporting, and medication safety.
The primary objectives of the CDER include facilitating timely access to safe and effective drugs, promoting public health by ensuring accurate drug information, and fostering innovation through regulatory science. This includes working closely with industry stakeholders, healthcare professionals, and patients to gather data and conduct studies that inform drug approval decisions and regulatory policies.
Overall, the CDER serves as a vital authority in the United States for drug evaluation, regulation, and safety, aiming to protect and promote public health by ensuring that drugs meet rigorous standards for quality, safety, and efficacy before they are available in the market.
