IHS Chemical Week

FDA Tallies Results from Global Effort Regulating APIs

2:08 PM MDT | August 11, 2011 | Deepti Ramesh

The U.S. Food and Drug Administration (FDA) and its international counterparts have released reports on the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally. The report on the active pharmaceutical ingredients (API) initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration, the European Medicines Agency (EMA), France, Germany, Ireland, Italy, the U.K. and European Directorate for the...


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