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Assessment of Violations Cited by OPDP in Untitled and Warning Letters Issued from 2004-2013

Time

Wed, Jun 18 7:15AM
W 23

Title

Assessment of Violations Cited by OPDP in Untitled and Warning Letters Issued from 2004-2013

Abstract Summary

We assessed enforcement letters found on the FDA website from 2004-2013. From each Untitled and Warning Letter, the following was evaluated: number and types of enforcement letters from OPDP/year, number of violations cited in each enforcement letter, average number violations/letter per year.

Poster Presenter

Phil Reveal
Meda Pharmaceuticals, Inc
United States