Blog
Doug Lowry steps in as Acting Director for NCI
Recently the National Cancer Institute (NCI) promoted its deputy director, Doug Lowry, to director with the sudden resignation of Harold Varmus, MD. Not only has the NCI been managing through the transition with a new director, it also has been dealing with new budget...
Gretchen Bowker moderates the June 22 morning session of the AFDO event in Indianapolis
We are pleased to announce that our own, Gretchen Bowker, will be moderating the Association of Food and Drug Officials (ADFO) meeting today June 22nd. The AFDO is holding their event this week from June 20th to June 24th in Indianapolis at the Sheraton...
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...
IMDMC workshop on June 25th. Register now
The Indiana Medical Device Manufacturers Council (IMDMC) is holding an event on the background of FDA regulation for those new to the medical device field. There will be multiple presentations, including one from Pearl Pathways’ Gretchen Bowker COO & RAC on,...
US FDA’s biosimilar guidance has some people concerned
After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...