PS CDER stands for "Pharmaceutical Science Clinical Development and Epidemiology Review" and is a term mainly used in the field of drug development and regulation.
PS CDER refers to a specific division within the Center for Drug Evaluation and Research (CDER), which is part of the U.S. Food and Drug Administration (FDA). CDER plays a crucial role in evaluating the safety and efficacy of pharmaceutical drugs before they are approved for public use. PS CDER focuses on the scientific assessment and analysis of clinical data and epidemiological studies related to drug development and post-marketing safety monitoring.
The main objective of PS CDER is to evaluate the clinical evidence provided by pharmaceutical companies regarding the safety and effectiveness of new drugs. This includes reviewing clinical trial data, analyzing the design and methodology of trials, and assessing the statistical significance of results. PS CDER also conducts epidemiological research to investigate the real-world safety and efficacy of drugs after they have been approved and are in use by the general population.
The PS CDER team consists of experts in various scientific disciplines, including pharmacology, biostatistics, epidemiology, clinical research, and regulatory affairs. They work closely with other divisions within CDER, as well as pharmaceutical companies, academic researchers, and healthcare professionals, to ensure that drugs being developed or already on the market are safe and effective for patients.
In summary, PS CDER is a division within CDER that specializes in evaluating clinical data and conducting epidemiological research to assess the safety and effectiveness of pharmaceutical drugs during the drug development and post-marketing stages.
