The Role of the Food and Drug Administration in Drug Development: On the Subject of Proarrhythmia Risk

The Food and Drug Administration (FDA) is responsible for the regulation of the pharmaceutical industry in the interest of protecting public health. The aim of this review was to outline the evolution and current role of the FDA in the development and approval of new drugs. Additionally, we describe current assessments of proarrhythmia risk to illustrate recent FDA initiatives intended to harness information technology to modernize the regulatory process. In order to identify the literature required to produce this review, search tools such as PubMed and Google Scholar were used to locate relevant web pages and articles. The job of the FDA is not only to ensure that high standards for drug efficacy and safety are applied to products available to American consumers and patients but also to balance the lengthy, costly process of maintaining these standards against the pressure to provide access to effective treatments earlier and without surplus expenditures. In order to provide expedited access to the newest effective therapies for critically ill patients in the safest way possible, the FDA has developed several accelerated pathways to fast-track drug approval. Through partnerships with industry and academic institutions, research is being conducted into how information technology can be integrated into the drug development process to improve its cost-effectiveness.