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

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

Informatica Multidomain MDM

A master data management solution is the glue that binds your systems and information together. It’s the single source of truth for your data-driven digital transformation, providing trusted, accurate, complete data for your customer experience program, marketing and sales operations, omnichannel retailing, supply chain optimization, governance efforts, compliance initiatives, and more.

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