Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US Centers for Disease Control and Prevention (CDC) using sequencing...