FDA Guidance on Adaptive Designs released

On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here.  According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the...

Register now for the Asia Pacific Device Summit

On March 10-11, 2016, the Asia Pacific Device Summit will be held in San Francisco, CA. This event will bring together medical device experts from Asia and the US. Click here for more information. Register for the event through Brandwood Biomedical, Pearl Pathways’...

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...