by Robert Seevers | Jan 21, 2020
In previous entries on the Pearl Pathways blog, I have discussed what to do when you are asked questions by regulators, when FDA inspectors show up at your facility, and when you receive an FDA Form 483. This time, I will address what to do when you get a Warning...
by Robert Seevers | Dec 12, 2019
What is a 483? It is an FDA form used by inspectors to list the non-compliant items that they found during the course of a facility inspection. In the previous entry in this series, we discussed what to do when the inspectors arrive. Now, let’s discuss what to do when...
by Robert Seevers | Nov 5, 2019
The previous entry in this series addressed that moment of panic you may feel when suddenly facing questions from regulators. This time, let’s talk about what to do when inspectors from a regulatory agency show up at your facility. Future topics will look at dealing...
by Robert Seevers | Jun 10, 2019
We have all experienced them: those moments when all you can say is, “Oh, No!” or perhaps, “Oh $%&@!” Such moments happen in the development lifecycle of a drug or device all too often. What you do and say next can have huge impact on your product. So, what...
by Robert Seevers | Apr 2, 2019
As the United States Food and Drug Administration (FDA) reviews investigational new drug applications (INDs) to permit research studies with potential drugs and New Drug Applications (NDAs) and Biologic License Applications (BLAs) to permit marketing of small molecule...