Day: May 4, 2017

This week, FDA and NIH released a template for clinical trial protocols that practically took away any excuses one may have to not write a good quality clinical protocol. This template was jointly developed by clinical trial experts at NIH and FDA for government-funded researchers, in collaboration with a non-profit group that was developing a … Read more

This week FDA released a Warning Letter* issued to a GMP vendor in India that points to a very important issue that all companies using vendors, specifically foreign vendors, should be aware of, namely, who is listed as the manufacturer on the Certificate of Analysis (COA). Is the vendor being truthful about its sub-vendors and … Read more