U.S. Food and Drug Administration Center for Drug Evaluation and Research

The U.S. Food and Drug Administration Center for Drug Evaluation and Research is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

“The success of our transformation can be attributed to the way we manage our data. Trusted data from Informatica fulfills our vision and delivers the operational efficiencies we require.”

Project Manager

U.S. Food and Drug Administration Center for Drug Evaluation and Research
Goals
  • Address business challenges arising from globalization, regulation, and market complexities
  • Create a 360-degree view of the global supply chain associated with products undergoing regulatory review
  • Manage complex product lifecycles more efficiently
Solutions
  • Use Informatica PowerCenter and Informatica Master Data Management (MDM) to integrate and master data from tens of thousands of facilities, business entities, and products—creating a single source of data truth
  • A business-to-business data exchange enables simplified, secure entry and electronic processing of product information
  • A centralized data warehouse leveraging Oracle enables report generation across the agency
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Results
  • Brings together policy, administrative, scientific, and operational data consistently across the product review process
  • Improves collaboration and communication with stakeholder groups sharing a single source of truth
  • Streamlines product lifecycle operations through a new electronic submission capability, enhancing quality, speed, predictability, and completeness of product reviews

Products & Services

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