Home » Heparin Scandal Places FDA Focus on International Harmonization
Heparin Scandal Places FDA Focus on International Harmonization
May 6, 2010
As should be clear from the foregoing, the FDA continues to put emphasis on companies taking a robust quality systems approach to compliance based not
just on FDA regulations, but international harmonization efforts such as the Global Harmonization Task Force (GHTF) and the International Conference on
Harmonization (ICH). Indeed, in 2008, in the wake of the heparin scandal, the FDA issued the first warning letter citing a company for non-compliance to
ICH standards. In 2009, the agency issued another warning letter citing ICH guidelines to Sumitomo Chemical Company Limited.