Federal Register Notice: FDA will hold a public meeting 4/20 to provide information and receive comments on the International Conference on Harmonization (ICH) in advance of its next Steering Committee and Expert Working Group meetings in Brussels, Belgium, which will take place 5/9-12. The 4/20 meeting will be from 9 a.m. to 5:30 p.m. at The DoubleTree Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. Contact Sema Hashemi, (301) 827-3050. The public meeting will seek input on initiatives related to current ICH efficacy guidelines and any need for further information both within and between existing guidances. These initiatives include electronic source data, clinical development plan summaries, Health Level 7 structured product labeling, and other initiatives including information exchange standards (e.g., Electronic Common Technical Document and terminology standards). To view this notice, click here.
