Implementing the FDA’s fillable forms has been challenging for many small companies. While the advantages of using the forms are clear, many companies find the process daunting. Fortunately, there are some easy paths to implementation that do not require large-scale process or system changes.
Monthly Archives: November 2009
FDA Fillable Forms
Responding to FDA Questions
Responding to FDA questions can be a challenge in the eCTD world. Companies often have a goal to respond to questions within a certain time frame. Short turnaround cycles force people to focus on content, and as a result, lifecycle management is often ignored. Over time this can lead to a messy submission with lots of appended information and orphaned responses.
It’s often challenging to figure out best practices under time pressure, so I’ve outlined some strategies to address this situation before it arises.
Too Many Hyperlinks!
Most eCTD publishing systems now come with tools to simplify the process of inserting and updating cross-document hyperlinks. These tools generally work well, save time, and enable publishers to incorporate late content changes without having to redo all their links.
So what’s the problem?
Did you ever get lost in a book with too many footnotes?
Welcome to The Eagle's Nest
Welcome to my new blog. I’m going to use this space to post answers to questions I get from my clients and discuss issues of general interest related to implementing eCTD processes. There are many aspects of electronic submissions that simply aren’t in the guidance, or the guidance is so broad that it is open to many interpretations. I plan to use this space to try to demystify the eCTD. I really believe that eCTD is not difficult to implement, but it is new and different.