CEB CDER stands for the Center for Drug Evaluation and Research, which is a division of the U.S. Food and Drug Administration (FDA). The Center for Drug Evaluation and Research is responsible for ensuring that safe and effective drugs are available to the public. It plays a crucial role in evaluating the safety, efficacy, and quality of prescription and over-the-counter drugs available in the United States.
The primary mission of CEB CDER is to protect and promote public health by regulating drug products and ensuring their safety and effectiveness. This involves reviewing new drug applications submitted by pharmaceutical companies, conducting research, and establishing regulatory standards for drug development and manufacturing.
The center employs a multidisciplinary approach, involving experts in various fields such as pharmacology, toxicology, clinical research, and chemistry, to evaluate drug products thoroughly. This diligent evaluation process includes the examination of preclinical and clinical data, as well as the assessment of the manufacturing facilities and processes used to produce the drugs.
CEB CDER also monitors and investigates reports of adverse drug reactions and ensures compliance with relevant regulations and guidelines throughout the lifecycle of a drug. Through its activities, the center aims to facilitate the availability of safe and effective drug therapies, while safeguarding public health by reducing risks associated with drug use.
Overall, CEB CDER plays a critical role in the regulation and oversight of drugs in the United States, ensuring that consumers have access to safe and effective medications.
