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.
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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.