EMA Seeks Feedback On Revamped Good Clinical Practices Guideline
This article was originally published in SRA
Executive Summary
The European Medicines Agency is seeking feedback on a modernized version of a 19-year-old guideline on good clinical practice (GCP) that has been updated to factor in improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting1,2.
You may also be interested in...
ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.