COVID Laboratory Testing Investigations
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) announced in a memo to State Survey Agency Directors (QSO-20-35-ALL) the resumption of certain routine surveys and inspections of healthcare providers...more