Written by Ms. Lydia Lacuesta, Regulatory Submissions Coordinator, Clinical Monitoring Research Program
The Regulatory Affairs Group of the Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., in support of the Office of Clinical Research Policy and Regulatory Operations at the National Institute of Allergy and Infectious Diseases, is responsible for preparing, submitting, and maintaining Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), and drug Master Files to ensure compliance with the Food and Drug Administration (FDA), International Conference on Harmonisation (ICH), and other applicable regulations. I have been with the group since 2006 as a Regulatory Submissions Coordinator. I coordinate the work flow between Regulatory and Document Control, and assist them in some of their electronic Common Technical Document (eCTD) administrative needs.
Journal publications are required for INDs, IDEs, and their amendments. These publications assist the FDA in their evaluation of proposed clinical investigations and when determining if the investigational product can be safely used in humans. Sometimes these academic research papers and journal publications are not accessible in PubMed, or access is restricted and requires registration, in which case I need to request them from the library. [editor's note: via interlibrary loan]
The Frederick Scientific Library always provides an outstanding level of support to our publication requests. We truly appreciate their kind and caring attitude. They realize the time-sensitive nature of our applications and they go out of their way to help. We are grateful for their professionalism, work ethic, and abilities.
The Frederick Scientific Library is an asset and a valued source to our research organization. It's such a great pleasure to work with them! Gold Star to all of you!!