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Latest posts
Last updated about 4 hours ago
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
about 4 hours ago
FDA does not issue approval announcements for every approval or drug label...
Withdrawn | Cancer Accelerated Approvals
about 6 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Verified Clinical Benefit | Cancer Accelerated Approvals
about 6 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Missouri Analytical Laboratories Inc - 615319 - 10/09/2024
about 7 hours ago
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces - 05/29/2025
about 7 hours ago
Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29...
Generic Drug Research-Related Guidances & Reports
about 9 hours ago
The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives...
Postmarketing Requirements and Commitments: Reports
3 days ago
The Food and Drug Administration Modernization Act of 1997 requires FDA to...
Untitled Letters
3 days ago
These letters are supplied by the CDER Freedom of Information Office and...
Digital Health Technologies (DHTs) for Drug Development
4 days ago
Digital Health Technologies (DHTs) for Drug Development
List of Active Radioactive Drug Research Committee (RDRC) Sites
4 days ago
List of Active RDRC Sites
Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
4 days ago
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...
PDUFA VIII: Fiscal Years 2028 – 2032
4 days ago
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.