Latest Federal Register Notices

Guide on How to Develop REMS Shared System
Federal Register notice: FDA makes available a draft guidance entitled “Development of a Shared System REMS.” 06/01/2018

ICH Guide on Q12 Post-approval Drug Changes
Federal Register notice: FDA makes available a guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonization.” 05/31/2018

Guide on Device Bench Test Reports
Federal Register notice: FDA makes available a draft guide entitled “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.” 05/31/2018

Guide on Drug-related Blood Pressure Effects
Federal Register notice: FDA makes available a draft guidance entitled “Assessment of Pressor Effects of Drugs.” 05/31/2018

Comments Sought on Trial Data Information Collection
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” 05/30/2018