Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs

Bioinformatics is the design and development of computer-based technology to support the life sciences (1). At FDA, bioinformatics means the design, development, and use of modern computer systems to efficiently and effectively manage the regulatory product information supply chain, along which medical product information travels among the many relevant organizations (eg, study data travel from applicants to FDA for product review; adverse events reports travel from industry and the public to FDA; drug prescribing information travels from FDA to the public). FDA is a critical link in this information supply chain, and ensuring the efficient exchange of drug information between FDA and its stakeholders is critical to FDA’s mission to protect and promote public health and to improve risk-benefit assessments of drugs (see Figure 1). FDA has made real strides in its effort to achieve a fully automated and interoperable infrastructure for managing the exchange of regulatory product information. For example: