Day: April 11, 2019

FDA needs to complete its assessment of foreign inspections program for drugs and food, something that was originally recommended in 2016. Specifically, GOA requested, and FDA agreed to evaluate the effectiveness of its foreign offices with regards to drug safety-related outcomes, such as inspections, import alerts, and warning letters. FDA told GAO that since 2016 … Read more

A “strange” news release by Zogenix announced that it received a Refuse-to-File (RTF) for its NDA for Fintepla, a breakthrough therapy designated (BTD) drug for epilepsy. There are many clues in this announcement that could be lessons for others. The strangeness of the news is in the details of the RTF issues: missing chronic non-clinical … Read more