As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guidance: Post-authorisation efficacy studies can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guidance: Post-authorisation efficacy studies can be found below.