WuXi AppTec Offers PTT Testing with BFT II Analysis

Posted by Jean Kringstad, Director In Vitro Services on May 22, 2018

Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.

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Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility

Wuxi AppTec Provides Wide Range of Consulting Services

Posted by Yvonne Leonard, Director of Marketing on May 15, 2018

Depend on the Industry Expertise and Broad Knowledge Base of WuXi AppTec’s Consulting Services

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Topics: Regulatory, FDA, consultant

WuXi AppTec Names former FDA Commissioner’s fellow as a Senior Scientific Director

Posted by Yvonne Leonard, Director of Marketing on May 01, 2018

We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.

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Topics: Regulatory, FDA, Scientific Director, consultant