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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,

Susan

Articles of Interest

Federal Register Announcement: Pilot Program to Evaluate Proposed Proprietary Name Submissions; Procedures to Register for Participation and Submit Data:
http://edocket.access.gpo.gov/2009/pdf/E9-23620.pdf

Manual of Policies and Procedures (MaPP) Announced: Procedures for Handling Requests for Proprietary Name Review:
www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM182730.pdf

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184399.htm

Potency of USP unit heparin changed as of October 1, 2009: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184687.htm 

www.usp.org/hottopics/heparin.html#Statement 

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Recent News from ISMP Newsletters

Misidentification of Alpha-numeric Symbols in Handwritten and Computer-generated Information http://www.ismp.org/newsletters/acutecare/articles/20090702.asp

How Colorful is too Colorful? http://www.ismp.org/newsletters/acutecare/articles/20090730.asp

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Med-ERRS Services

****** Please contact us for our 2009 pricing******

  • 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.
  • SCREEN-ERR: Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
  • Package and Label Evaluation : Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and world wide regulatory authorities.
  • Safety Consulting : Provides consultative services which are related to a variety of medication safety-related issues. 
  • 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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