Wyeth calims no GCP lapse as India suspends vaccine trial - update
This article was originally published in Scrip
Executive Summary
Wyethbelieves that there have been no GCP (good clinical practice) lapses in its now suspended Indian pneumococcal conjugate vaccine trial. The Drugs Controller General of India (DCGI) has suspended these trials following the death of an infant, alleging that the company had flouted the inclusion-exclusion criteria for the study.