Comments submitted regarding FDA & OHRP joint draft guidance Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs. (Docket number: FDA-2015-D-3638). Click here to read the comments and impact on ACRP Members.
Comments submitted regarding Scientific guidance on post-authorisation efficacy studies. (Identifier: EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015). Click here to read the comments and impact on ACRP Members.