FDA BRIEF: Week of Feb 19, 2018
CDER Warning Letters
Provided by CDER Freedom of Information Office (FOI)
- Some have been redacted or edited to remove confidential information
- Matters may have been subject to subsequent interaction between FDA and the recipient that may have changed the regulatory status
Types of Letters
- Office of Prescription Drug Promotion Letters
- Office of Compliance/Immediate Office
- Office of Manufacturing Quality Letters
- Office of Scientific Investigations Letters
- Office of Drug Security, Integrity and Recalls
PDUFA VI Information Technology Goals and Progress
Goal of improving predictability and consistency of electronic submission process
- Electronic Submission Documentation
- Electronic Submission and System Status
- Electronic Submission Gateway (ESG) Target Timeframes, Milestones and Notifications
Enhance transprency and accountability of electronic submission and data standards activities
- IT Public Meetings
- Electronic Submissions Performance Metrics
- Data Standards
Image credit: FDA