title: Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.
abstract: Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.
authors.affiliation: U.S. Food and Drug Administration (FDA), Rockville, MD 20852, USA. JeffreyK.Smith@fda.hhs.gov
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Smith
mesh_terms: D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D016208:Databases, Factual / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D033161:Government Regulation; D063025:Health Information Management / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D006291:Health Policy; D006801:Humans; D016247:Information Storage and Retrieval / Q000331:legislation & jurisprudence; D009937:Organizational Objectives; D018570:Risk Assessment; D012307:Risk Factors; D018511:Systems Integration; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D057188:Workflow; D016526:Workload
chemical_list: D001688:Biological Products