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Latest posts
Last updated about 3 hours ago
FDA approves durvalumab for muscle invasive bladder cancer
about 3 hours ago
On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi...
FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
about 5 hours ago
Today, the U.S. Food and Drug Administration approved a novel treatment for...
Scientific Public Private Partnerships and Consortia
about 6 hours ago
Find out how CDER works with partners and consortia to identify science...
What's New Related to Drugs
about 7 hours ago
Want to know what's new on drugs from FDA? This page provides...
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
about 7 hours ago
On March 28, 2025, the Food and Drug Administration expanded the indication...
Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
about 9 hours ago
To help address challenges associated with ensuring data quality and integrity in...
CDER Small Business & Industry Assistance (SBIA)
about 9 hours ago
A Comprehensive Resource for Information on Human Drug Development in Regulation
Generic Drugs Forum (GDF) 2025 - 04/09/2025
about 9 hours ago
Join us at the annual Generic Drugs Forum, a two-day event designed...
C3TI Areas of Interest
about 10 hours ago
C3TI's areas of interest span drug development programs, therapeutic areas, and disciplines...
Notifications on Data Integrity
about 11 hours ago
FDA notifications for industry on data integrity.
FDA to pharmaceutical companies: Certain studies conducted by Raptim Research Pvt. Ltd. are unacceptable
about 11 hours ago
FDA has identified significant data integrity and study conduct concerns with bioequivalence...
CDER Center for Clinical Trial Innovation (C3TI)
1 day ago
Enable and amplify existing and future CDER clinical trial innovation through enhanced...