Regulatory Open Forum

We plan to send out a Dear Dr Letter to notify investigators of a new safety event for our investigational drug. Do we need to submit this Dear Dr. Letter to FDA for review first before sending to investigators ?

There is not a regulatory requirement to submit a Dear Dr Letter to FDA before sending to investigators. However, you should read the January 2014 Final Guidance, Dear Health Care Provider Letters:  Improving Communication of Important Safety Information to understand FDA's expectations on how they might contribute to the content of the letter. This Guidance is relevant for safety communications throughout a product life cycle. If it is a new safety event that your company believes requires communication to investigators, it seems likely that you will have already submitted the safety information to FDA. Depending on the urgency of the communication, I would expect that FDA would give very high priority to reviewing and commenting on your proposed letter.