OCP CDER stands for Office of Clinical Pharmacology, Center for Drug Evaluation and Research. It is a division of the U.S. Food and Drug Administration (FDA) that focuses on the evaluation and regulation of drugs, particularly from a clinical pharmacology perspective.
The OCP CDER plays a vital role in ensuring the safety and efficacy of drugs that are marketed in the United States. It is responsible for providing scientific and regulatory advice to drug developers, and for evaluating the pharmacokinetics, pharmacodynamics, and drug-drug interactions of new drugs.
The main objective of the OCP CDER is to promote the understanding and application of clinical pharmacology principles in drug development and regulatory decision-making. This involves conducting research, developing guidance documents, and providing training to FDA staff and the broader scientific community.
The OCP CDER collaborates closely with other divisions within the FDA, as well as other regulatory agencies and academic institutions, to gather and analyze scientific data related to drug development and safety. It also works on developing and implementing policies and regulations to ensure that drugs on the market are safe, effective, and of high quality.
Overall, the OCP CDER is responsible for advancing the field of clinical pharmacology and ensuring that medicines available to patients are thoroughly evaluated for safety and effectiveness.
