CBER to Require SPL?

One of the rumors coming out of DIA Annual is that CBER may soon (October timeframe) require all biologics marketing applications to use Structure Product Labels (SPL) for their labeling requirements.

This would be another interesting move forward as FDA continues to lead the way as far as electronic submissions go globally. We'll have to wait to find out exactly when this becomes a reality but if so remember you heard it hear first. :)