Members of the Committee:
The FDA has provided the Committee with a number of studies to review. What is the process the committee is going to use which would allow members of the public to submit comments on the said studies? Please provide a response in order that we may publish your response on our Interactive Public Docket on this matter.
To this end, we have completed an initial review of one of the studies identified by FDA and have provided our results to the authors of study.
Will you provide TPSAC not only with FDA studies recommend for their consideration, but also peer reviews supplied by the public?
Center for Regulatory Effectiveness