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Adverse event reporting units in merging drug firms need to be clearly established -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

ADVERSE EVENT REPORTING UNIT ESTABLISHMENT IN MERGING FIRMS suggested by FDA Office of Compliance New Drug Policy Development and Case Review Team Leader Fred Richman at a Food & Drug Law Institute meeting on adverse event reporting and drug surveillance Nov. 19 in Washington, D.C. As the trend toward mergers within the pharmaceutical industry continues, "it is essential that the unit in the newly merged companies that is responsible for adverse drug experience reporting is clearly identified and established if one didn't already exist and then carry out its function based on a clear and well-defined set of standard operating procedures," Richman said.
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