In November 2017, FDA released their final guidance on unique device identifier (UDI) entitled, “Unique Device Identification: Direct Marking of Devices.” The guidance highlights the importance of direct marking for devices... read more →
The Annual Meeting for the Society of Toxicology, SOT 2018, kicks off March 11th in San Antonio, Texas. The program consists of more the 160 scientific sessions including symposiums, workshops,... read more →
A biological evaluation is a weight of evidence. It consists of materials characterization – approached through extractables and leachables studies; toxicological risk assessment, and biocompatibility – to address local and... read more →
When the FDA releases a guidance to the industry, such as the 2015 Guidance on Reprocessing Medical Devices, it is often applicable to devices subject to clearance and approval in... read more →
Demand for extractables and leachables studies increases as industry and regulatory bodies adopt the ISO 10993 approach to Biological Evaluations. Similar to the role materials characterization plays in device design... read more →
WuXi AppTec Selected by IQVIA Stem Cell Center to Serve as GMP Manufacturer of Advanced Therapies WuXi AppTec (WuXi), a leading global pharmaceutical, biotechnology and medical device open-access capability and... read more →
Expedite Entry Into Clinical Trials With The WuXi Hyper-PRO Platform For Viral Vector Manufacturing Introduction With the increasing demand for GMP (Good Manufacturing Practice) viral vector production – a critical... read more →
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