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 posts an International Council for Harmonization draft guideline entitled E20 Adaptive Designs for Clinical Trials that provides recommendations o...
FDA issues an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets due to device performance issues.
FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government shutdown goes into ef...
