Medical News Update
- Newly Added Guidance Documents
- M11 Clinical Electronic Structured Harmonised Protocol
- Generic Drug User Fee Amendments
- BsUFA IV: Fiscal Years 2028-2032
- Untitled Letters
- Generic Drug Facilities, Sites and Organization Lists
- First Generic Drug Approvals
- 2025 First Generic Drug Approvals
- HIV Treatment
- CDER Small Business & Industry Assistance (SBIA)
- Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
- Prescription to Nonprescription Switch List
- What's New Related to Drugs
- Oncology (Cancer)/Hematologic Malignancies Approval Notifications
- FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
- Drugs@FDA Data Files
- President's Emergency Plan for AIDS Relief (PEPFAR)
- GDUFA Paid Facilities List
- Prescription Drug User Fee Amendments
- Human Drug Compounding Outsourcing Facility Fees