Drug Development and Food and Drug Administration (FDA) Regulations

This CTSC workshop provides an overview of the drug development process, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) processes. It is ideal for early-stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process. The course will provide a review of the steps that lead up to the clinical trial process. The phases of clinical development that are part of the Investigational New Drug (IND) application (the actual human trials that are conducted to demonstrate safety and efficacy in order for regulatory authorities to approve investigational drugs for marketing) will be discussed. The New Drug Applications (NDA) process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.