Newsletter - April 11, 2019
Silly Mistakes Lead to Refuse to File From FDA for Breakthrough Therapy
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 study, and incorrect version...Read More
GAO Wants FDA to Assess its Foreign Inspections for Drugs and Food
FDA needs to complete its assessment of foreign inspections program for drugs and food, something that was originally recommended in 2016. Specifically, GAO 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...Read More
Silly Mistakes Lead to Refuse to File From FDA for Breakthrough Therapy
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 study, and incorrect version...Read More
GAO Wants FDA to Assess its Foreign Inspections for Drugs and Food
FDA needs to complete its assessment of foreign inspections program for drugs and food, something that was originally recommended in 2016. Specifically, GAO 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...Read More
