FDA CBER Product Review & Approval
Investment ID: 009-000463864
Overview
Program Title
FDA CBER Product Review & Approval
Description
The purpose of this investment is to evaluate Investigational New Drugs and new product applications from industry to determine their safety and effectiveness before they can be marketed to the public. This ability enables reviewing, tracking, and documentation of regulatory decisions and actions taken on investigational and marketing applications and notifications, pre-applications, master files, EUAs, meetings and related submissions.
Type of Program
Non-major IT Investments
Multi-Agency Category
None