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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
Recent enforcement actions include convictions and guilty pleas for false claims-related allegations involving toxicology labs.
Recent enforcement actions show that clinical laboratories must remain vigilant about compliance relating to these areas
Recent efforts to forecast the next infectious disease outbreak and steps labs can take to ensure they’re prepared.
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.