Medical News Update
- Generic Drug User Fee Amendments
- Generic Drug Facilities, Sites and Organization Lists
- ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
- CDER proposes to withdraw approval of TAVNEOS
- What's New Related to Drugs
- Oncology (Cancer)/Hematologic Malignancies Approval Notifications
- C3TI Compass (Knowledge Repository)
- FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
- Drugs@FDA Data Files
- CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
- FDA Actions to Support and Strengthen Domestic Drug Manufacturing
- FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
- eCTD Submission Standards for eCTD v4.0 and Regional M1
- Patient Listening Session Summaries
- eCTD Submission Standards for eCTD v3.2.2 and Regional M1
- The FDA at 120: A Long, Distinguished History Protecting Americans
- Preparing Patient and Caregiver Participants for an FDA Patient-Led Listening Session and Suggested Topics
- Drug Repurposing: Considerations for Selection Criteria and Prioritization - 08/05/2026
- Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
- PDUFA and BsUFA Quarterly Hiring Updates