Volume 2, Issue 4 UPDATE-ERR™ Autumn 2009

President's Messaage

Autumn 2009

Greetings to all of our friends and colleagues! In this issue of the UPDATE-ERR, we bring you news of several FDA announcements—one related to Risk Evaluation and Mitigation Strategies (REMS), and two related to trademark review.

Safe use of heparin continues to be a much-discussed topic, with the recent changes in the reference standards that took effect on October 1.
As we enter the remaining weeks of 2009 (which for many coincides with budget season!), it is not too late to commission projects for this year, nor is it too early to plan for 2010.

With best wishes for a happy holiday season,


Articles of Interest

Federal Register Announcement: Pilot Program to Evaluate Proposed Proprietary Name Submissions; Procedures to Register for Participation and Submit Data:

Manual of Policies and Procedures (MaPP) Announced: Procedures for Handling Requests for Proprietary Name Review:

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies:

Potency of USP unit heparin changed as of October 1, 2009: 

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  • Trademark Evaluation: Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODELTM, which incorporates various techniques recommended by the FDA to evaluate the safety of trademarks.
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  • EVALUATE-ERR: Conducts an in-depth analysis of error reports using data from the client as well as other medication error databases.


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