A recent Biden administration report on “significant” foreign barriers to U.S. exports suggests that a battle may be brewing over clinical trial transparency.
Late last month, the U.S. Trade Representative issued its latest annual look at foreign trade and, in a section devoted to the European Union, noted a European Medicines Agency policy toward disclosing clinical trial data is problematic. Specifically, the report referred to the “potential disclosure” of trade secrets in clinical study reports submitted by drug companies to the EMA for marketing approval.
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