USFDA's eCTD 4.0 Update: Key Takeaways
The regulatory landscape has been abuzz with anticipation for the USFDA's update on eCTD v4.0. Regulatory professionals and life sciences companies have been eagerly awaiting news on the next steps for this critical submission format. Finally, a few months ago, the USFDA announced that, starting from September 16, 2024, they would support the electronic submission of eCTD v4.0 for new applications.