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Latest posts
Last updated about 5 hours ago
What’s New in Clinical Trial Innovation
about 5 hours ago
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial...
Clinical Trials Day
about 6 hours ago
Clinical Trials Day is celebrated on May 20, in recognition of what...
BsUFA IV: Fiscal Years 2028-2032
about 6 hours ago
On September 30, 2022, the President signed into law the FDA User...
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
about 10 hours ago
This webpage provides links to certain publicly available external reports and resources...
Understanding Drug Recalls: What to Know and What to Do
about 11 hours ago
Find out what to do if your medication is recalled. Learn how...
FDA approves selpercatinib for medullary thyroid cancer with a RET mutation
about 11 hours ago
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo...
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
about 12 hours ago
On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib...
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
1 day ago
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors...
OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration - 05/05/2026
1 day ago
The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments...
Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls
1 day ago
Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls
Sleep, Skin, Bodybuilding and Other Product Notifications
1 day ago
Learn about the warnings for sleep, skin and bodybuilding products that contain...