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Helping the FDA Review Pharmaceuticals

CSC has teamed with SRA to maintain the Food and Drug Administration (FDA) database and software systems that support the review and approval of biologically derived drugs and blood products.

The system, called the Regulatory Management System – Biologics Licensing Application (RMS-BLA) is both a repository and process. It contains historical data on biologics approved by the FDA. The FDA uses it to manage reviews of new biologics that pharmaceutical companies seek to market and to track and act on changes affecting previously approved products.

After completing clinical trials for a biologic product, the pharmaceutical company submits a BLA incorporating the clinical data to the FDA for product approval/licensing. The application is routed to the appropriate FDA office, which designates a review committee. At this juncture, significant data about the product itself, the facility where it is to be produced, and elements of the review process, including key milestones, guidelines, and evolving application status are incorporated in and tracked by RMS-BLA.

RMS-BLA’s role continues even if the biologic product is licensed for public distribution. For example, it records and tracks any post-marketing commitments FDA imposes on the product. Pharmaceutical companies are also required to submit new information if there are changes in product formulation, production facilities, or label texts. The changes are then cycled through the approval process.

The RMS-BLA software also evolves with user needs, such as generating new reports and responding to legislation affecting the review process.

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