FDA CDER Regulatory Review Platform
Investment ID: 009-000331763
Overview
Program Title
FDA CDER Regulatory Review Platform
Description
The Regulatory Review Platform (RRP) facilitates the creation and implementation of a modern, efficient and integrated drug application review capability for the FDA's Center for Drug Evaluation and Research (CDER). Prior to RRP, the drug application review processes were segregated or siloed, primarily between new drugs, generic drugs and biologics, and separate offices used separate information systems. RRP improves information sharing, facilitates collecting regulatory metrics and Congressional reporting, reduces redundant data and processes, and mitigates the need for costly modifications on legacy systems.
Type of Program
Major IT Investments
Multi-Agency Category
Other
Investment Detail
The Return on Investment (ROI) is being realized directly and indirectly in multiple channels, specifically, in replacing a hand tailored, limited use software product with industry standard COTS, supported data, workflow and data marketplace tools for regulatory information. This replacement alone is reducing time (design and development) and effort (cost of implementation) to keep systems updated to changing business requirements and mandates. It is expanding to accommodate the expected increases in New Drug and Generic Drug Approval volume, plus reduce Generic Drug approval backlog. System replacement is improving background IT utilization, by reducing the number of operating systems, software and hardware licenses and manpower required versus the multiple compartmentalized stove pipe tailored systems currently in use. Upgrades will be supported by COTS vendors and supporting contractors working throughout the industry with these tools. Standardizing the data, workflow and data marketplace tools is improving efficiency of processes, reducing process redundancy, and lowering training costs versus the multiple systems used prior to RRP. Risk is greatly reduced as a scalable system is in place to carry the weight of increased review workload and new requirements for quicker turnaround (PDUFA, BsUFA and GDUFA ). Security is requiring less manpower to manage with a lower number of software and hardware systems to monitor. Direct benefit will continue to improve process efficiency reducing the time to approval of regulated drugs, allowing more drugs to be approved annually in a growing drug approval pipeline. Changes to process driven by Government or Scientific mandates will be easier and less expensive to accommodate on widely used industry generic tools, rather than hand tailored single use software. Retired system costs and O&M for legacy systems can be used in incrementally improving the Informatics Platform processes and supporting equipment. The RRP Business Case predicted a five year Organizational Cost Savings of $78 million, and an additional Stakeholder Benefit of $24 million. RRP allows CDER to meet drug review efficiencies as specified in the PDUFA, GDUFA and BsUFA commitments and provides a path for faster consumer access to health care products.