FDA Office of Clinical Pharmacology Announces Availability of 2018 Annual Reports - Drug Information Update

The Food and Drug Administration (FDA), Office of Clinical Pharmacology (OCP) announces the availability of the 2018 Annual Reports for the Office of Clinical Pharmacology (OCP) and its Division of Applied Regulatory Science (DARS). OCP’s mission is to play a pivotal role in advancing development of innovative new medicines by applying state-of-the-art scientific principles; and promote therapeutic optimization and individualization through best practices in research, policy development, and drug evaluation throughout the product lifecycle. The 2018 Annual Reports highlight OCP’s important work towards a vision of improving public health by building and translating knowledge of drug-response into patient-centered regulatory decisions of the highest quality.   DARS is a multidisciplinary research division of OCP that integrates scientific innovation and regulatory review. DARS forms teams “on-demand” to perform mission-critical research and expert regulatory review consultations. In 2018, DARS responded to multiple urgent needs in many CDER and FDA priority areas that spanned all areas of drug development.    Learn more about OCP’s diverse functional responsibilities, value-focused culture, 2018 achievements, and 2019 outlook found in the 2018 OCP and DARS Annual Reports at the following links: 2018 OCP Annual Report, 2018 DARS Annual Report. Past OCP annual reports can be found at: Reports and Budgets (CDER).