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Heparin
In Wake of Heparin Scandal, US Trade Official Blasts China on Drug Safety
Apr 25, 2008 | Parker Waichman Alonso LLP
Christopher Padilla, the under secretary of commerce for international trade, told a group of businessmen that the United States was concerned that...
Scientists Show Chemical in Tainted Heparin Caused Illnesses
Apr 24, 2008 | Parker Waichman Alonso LLP
Scientist now know why contaminated heparin caused serious and sometimes fatal reactions in hundreds of patients. In a study published in the...
FDA Issues Chinese Heparin Supplier Warning Letter After Finding Conditions Unsuitable
Apr 24, 2008 | Parker Waichman Alonso LLP
An inspection by U.S. regulators of the Chinese factory that supplied tainted heparin ingredients to Baxter International revealed significant...
Chinese Complete Inspection of Baxter Heparin Plant
Apr 23, 2008 | Parker Waichman Alonso LLP
Chinese inspectors have visited the Baxter International plant in New Jersey where the final processing of tainted heparin took place. The Food...
Heparin Mess Leads to US, China Dispute
Apr 22, 2008 | Parker Waichman Alonso LLP
Tainted heparin has officials from the U.S. and China at odds, with each blaming the other country's manufacturing for problems with the drug. ...
FDA Slams Conditions at Chinese Plant Implicated in Heparin Debacle
Apr 22, 2008 | Parker Waichman Alonso LLP
Conditions at the Chinese plant that produced a raw ingredient for tainted heparin have been deemed "unsuitable" by the US Food & Drug...
FDA Inspections of Foreign Drug Makers Still Lacking, GAO Audit Says
Apr 22, 2008 | Parker Waichman Alonso LLP
The Food & Drug Administration (FDA) is inspecting more foreign drug makers than it once did, but is still only conducting a fraction of the...
Heparin Problems Not Our Fault, Chinese Official Says
Apr 21, 2008 | Parker Waichman Alonso LLP
A counterfeit ingredient found in batches of recalled heparin is not to blame for the deaths and reactions seen in U.S. patients treated with the...
FDA China Office Slated to Open in October
Apr 15, 2008 | Parker Waichman Alonso LLP
A month from now, the US Food & Drug Administration (FDA) could have full-time personnel on the ground in China, provided the Chinese government...
FDA Commissioner Says Heparin Contamination Probably "Fraud"
Apr 15, 2008 | Parker Waichman Alonso LLP
A heparin ingredient sourced from China was likely intentionally replaced with a counterfeit ingredient, the head of the Food & Drug...
Heparin
