On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial ...
In 2025, the U.S. Food and Drug Administration (“FDA”) and U.S. Department of Justice (“DOJ”) pursued significant criminal, ...