FDA CDER Safety Data and Analytics (SDA)
Investment ID: 009-000393298
Overview
Program Title
FDA CDER Safety Data and Analytics (SDA)
Description
SDA will enable FDA to efficiently, effectively and reliably define substances and maintain unique identifiers for substances in drugs, biologics, foods and devices.
Type of Program
Non-major IT Investments
Multi-Agency Category
Other
Investment Detail
The SDA investment will benefit internal and external users in several ways, including enable early detection, assessment, minimization and communication of risks of drugs and therapeutic biologic products in the U.S. throughout their lifecycle; Facilitate statistical analyses of adverse reported events; Delivers an Enterprise connection between Principal Investigators, Health and Safety Officers, and Occupational Medicine; Provide a robust data entry, searching, and navigation in compliance with the ISO 11238 standard; Enable data to be readily integrated with the legacy data sources; Contain APIs that allow various information to be pulled from SDA into other data repositories and analytic systems; Maintain a useable interface to link and retrieve relevant information; Enable early detection, assessment, minimization and communication of risks of drugs and therapeutic biologic products throughout their lifecycle.