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Latest posts
Last updated about 10 hours ago
CDER proposes to withdraw approval of TAVNEOS
about 10 hours ago
CDER proposes to withdraw approval of TAVNEOS
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/30/2026
about 11 hours ago
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
SBIA Resources in Chinese 中文信息
about 12 hours ago
Small Business Business and Industry Assistance resources in Chinese
Video and Transcript: FDA|CDER’s Small Business and Industry Assistance (SBIA)
about 13 hours ago
The journey to develop and market a human drug can be long...
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
about 16 hours ago
FDA does not issue approval announcements for every approval or drug label...
Withdrawn | Cancer Accelerated Approvals
about 18 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Verified Clinical Benefit | Cancer Accelerated Approvals
about 18 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Missouri Analytical Laboratories Inc - 615319 - 10/09/2024
about 19 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 19 hours ago
Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29...
Generic Drug Research-Related Guidances & Reports
about 21 hours ago
The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives...
Postmarketing Requirements and Commitments: Reports
4 days ago
The Food and Drug Administration Modernization Act of 1997 requires FDA to...
Untitled Letters
4 days ago
These letters are supplied by the CDER Freedom of Information Office and...