BLOGS

FDA just posted a Draft Guidance "Considerations for Complying With 21 CFR 211.110" ( https://www.fda.gov/media/184825/download ) in Jan...

Did you know that Office of Combination Products (OCP) at FDA was established in 2002 as required by Sec. 204 of the Medical Device User...

What is release by exception? In manufacturing, there are instances where things may not always go as planned. It can be minor or major...