FDA rule aims to boost quality of safety data from drug trials

09/28/2010 | Wall Street Journal, The

The FDA issued a rule that requires companies testing experimental drugs or medical products to inform the agency within 15 days about serious risks and adverse reactions that arise during clinical studies. The measure, which takes effect March 28, "will expedite FDA's review of critical safety information" and "will better protect people who are enrolled in clinical trials," an FDA official said.

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