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Last updated 1 day ago
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
1 day ago
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
CDER proposes to withdraw approval of TAVNEOS
1 day ago
CDER proposes to withdraw approval of TAVNEOS
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
1 day ago
On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda...
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
2 days ago
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
2 days ago
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
FDA Actions to Support and Strengthen Domestic Drug Manufacturing
2 days ago
The FDA is taking decisive steps to strengthen U.S. pharmaceutical manufacturing, improve...
Patient Listening Session Summaries
3 days ago
Patient Listening Session summaries are published after each session to share a...
eCTD Submission Standards for eCTD v4.0 and Regional M1
3 days ago
A listing of the Implementation Guides, Specifications, and Documentation that support the...
The FDA at 120: A Long, Distinguished History Protecting Americans
3 days ago
Since 1906 Americans have relied on, and benefited from, the FDA’s oversight...
Drug Repurposing: Considerations for Selection Criteria and Prioritization - 08/05/2026
3 days ago
On August 5, 2026, the Reagan-Udall Foundation for the FDA, will convene...
Preparing Patient and Caregiver Participants for an FDA Patient-Led Listening Session and Suggested Topics
3 days ago
Learn about topics that are outside of the scope of FDA’s work...