Reports & Budgets | CDER
Reports and budgets from CDER offices and divisions
Budgets
Reports
Scientific Progress from CDER Offices and Divisions
- Office of Translational Sciences 2022 Annual Report
- Office of Clinical Pharmacology Annual Reports
- Division of Applied Regulatory Science Annual Reports
- Office of Pharmaceutical Quality Annual Reports
- Office of Generic Drugs (OGD) Annual Reports
- Office of New Drugs Annual Reports
User Fee Agreement Reports
- Prescription Drug User Fee Act (PDUFA) Annual Reports and Plans
- Generic Drug User Fee Amendments (GDUFA) Annual Reports and Plans
New Approvals Reports
Additional Reports
- Workshop Report: Enhancing Clinical Study Diversity | June 2024 (PDF - 624 KB)
- Meeting Report: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies | January 2024 (PDF - 279 KB)
- Report to Congress: The Listing of Patent Information in the Orange Book | December 2021
- Advances in FDA's Drug Safety Programs (annual reports)
- Drug Shortages: Root Causes and Potential Solutions
- Annual CDER Reports to Congress
- Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data
- Pediatric Reports
- FDA's Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act | January 2017
- The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative
- FDA Reports
- Congressional Testimony
- Reports and Plans Mandated by FDASIA