FDA clears a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform.
FDA warns San Francisco, CA-based dentist Pamela Den Besten about conducting a clinical trial on an investigational drug without an IND in place.
FDA warns Glendale, CA-based Persōn & Covey about CGMP violations in its production of unapproved drugs.
In an unprecedented LinkedIn post, CDER director George Tidmarsh questions the use of surrogate endpoints and publicly attacks Aurinia Pharmas Lupus d...
The CDER Quantitative Medicine Center of Excellence issues a report on goals and accomplishments in the first 16 months of its existence.
An HHS contingency plan says FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government.
FDA approves a Zoll Medical PMA for Zenix, the companys newest monitor/defibrillator, which the company says is designed to streamline emergency and h...
FDA researchers say the OND Custom Medical Queries developed to improve the identification and analysis of new drug safety signals have improved FDAs ...
