Day: March 30, 2017

This week European Medicines Agency (EMA) announced suspension of the approval of 331 drugs due to gross data integrity violations at an Indian CRO. This is the third episode of its kind in the last 2 years and exposes a major defect in the regulatory review process in EU. One wonders how the CROs managed … Read more

The FDA’s Office of Regulatory Affairs (ORA), which is responsible for all audits conducted by FDA, is undergoing a major reorganization starting 17th May this year, which is expected to dramatically change how FDA audits. ORA will distribute its auditors into five specialized commodity-based groups, plus one group for clinical trial audits. This is radically … Read more