Ranbaxy Internal Audit Disclosure Highlights U.S. FDA Policy Exceptions
This article was originally published in PharmAsia News
Executive Summary
Ranbaxy's uphill battle to keep U.S. FDA from seeing a consultant's audit reports provides a sobering reminder of the circumstances under which the agency will seek to review such documents - and the pressure it can exert on a company to release them
You may also be interested in...
FDA Launches First Overseas Office In Beijing
Eight FDA staffers in three offices face language, volume challenges watchdogging 500 plus Chinese firms exporting drug components to the U.S.
U.S. FDA Launches First Overseas Office in Beijing
U.S. HHS Secretary Michael Leavitt and U.S. FDA Commissioner Andrew von Eschenbach officially opened the first overseas FDA office Nov. 19 in Beijing in a continuing effort to improve foreign product safety, while the agency faces criticism from the U.S. Congress
FDA Launches First Overseas Office In Beijing
Eight FDA staffers in three offices face language, volume challenges watchdogging 500 plus Chinese firms exporting drug components to the U.S.