Come see Sarah Witwer teaching at Grace College

Sarah Witwer will be teaching for the third time in Orthopedic Regulatory and Clinical Affairs Program this fall at Grace College. She has three decades of practice in the life science industry and is a Pearl Pathways Regulatory Compliance Advisor. Sarah is well...

Pearl Pathways to partner with Brandwood Biomedical

Pearl Pathways is pleased to announce a global partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia. This collaboration allows both companies to provide on-the-ground support to clients...

FDA issues final guidance document on IDE submission decisions

FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...

Intel and Michael J. Fox Foundation partner for Parkinson’s study

The use of wearable medical technology has become less of a hypothetical concept and more of a reality as industry representatives begin to experiment with the idea. Intel and the Michael J. Fox Foundation have joined forces to conduct a study using smartwatches to...

First INpact meeting of 2013

Pearl staff is attending the first INpact lunch meeting of 2013 on Wednesday, January 23rd.   INpact is focused on supporting the medical device industry in Indiana. Please attend the lunch to network and learn more about the new bimonthly meeting format. Time: ...

Supplementary data research causing unnecessary expenditures

Ken Getz, assistant professor at Tufts Center for the Study of Drug Development (CSDD), reports that oftentimes procedures performed in the last drug development stages are in order to find “supplementary, secondary, tertiary, and exploratory endpoints.”...