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Latest posts
Last updated about 1 hour ago
What’s New in Clinical Trial Innovation
about 1 hour ago
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial...
Clinical Trials Day
about 2 hours ago
Clinical Trials Day is celebrated on May 20, in recognition of what...
BsUFA IV: Fiscal Years 2028-2032
about 2 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 7 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 7 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 8 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 8 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
about 21 hours 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
about 24 hours 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...