RAPS

FDA Updates Bioanalytical Method Validation Guidance to Include Biomarkers, Diagnostics

A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license applications (BLAs) and ...
MarketWatch

Drug Analytical Method Validation, Verification and Transfer Virtual Seminar (Jan 14th - Jan 15th, 2026 and On-Demand) - ResearchAndMarkets.com

The "Analytical Method Validation, Verification and Transfer Virtual Seminar (Jan 14th - Jan 15th, 2026)" training has been added to ResearchAndMarkets.com's offering. Dependable analytical results ...
RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
technologynetworks

Regulatory Considerations for Clinical Proteomics in Diagnostic Laboratories

The successful translation of biomarker discoveries into actionable diagnostic tools requires strict adherence to the robust regulations governing clinical proteomics. As mass spectrometry and ...