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Volume 3, Issue 1 UPDATE-ERR™ Winter 2010

President's Messaage

Winter 2010

Dear Friends and Colleagues,

We hope 2010 is treating you well so far, and we have good news to report: Med-ERRS has not raised prices for 2010. We have been working diligently on numerous trademark, packaging and consulting projects, and have recently expanded testing capabilities into additional countries. We also have adapted our international trademark safety testing service to provide an overall "EU view." Please let us know if you would like additional information about this service.

Regarding the PDUFA IV Pilot Project, Med-ERRS is working collaboratively with a sponsor, assisting with activities to fulfill a "Concept Paper" submission. We would be happy to discuss adapting this process to your trademark development process.

Please let us know if you will be attending PTMG in Liverpool, as Med-ERRS will be in attendance.

With best wishes,

Susan

Articles of Interest

FDA finalizes Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names

Guidance can be found here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068

Federal Register Announcement can be found here: http://edocket.access.gpo.gov/2010/2010-2660.htm

ISMP featured in Wall Street Journal article:
http://online.wsj.com/article/SB10001424052748703626604575010932945077528.html

Med-ERRS staffer interviewed by PharmaVoice regarding PDUFA IV Pilot Program: http://www.mmsend3.com/ls.cfm?r=51375848&sid=8411003&m=909526&u=
PharmaV&s=http://www.pharmavoice.com/pdfs/2010/pv-0110/PV0110_BrandPilotProgram.pdf

Ask an Expert

If you have a question related to one of Med-ERRS services or have an industry-specific inquiry, please Click Here and one of our experts will get back to you with an answer.

 

News from ISMP

Some insight into drug name modifiers (suffixes) and their meanings http://www.ismp.org/Tools/drugnamesuffixes.pdf

Barcode standardization moves forward in Canada 
http://www.ismp-canada.org/barcoding/index.htm

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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.


Med-ERRS

200 Lakeside Dr, Suite 200
Horsham, PA 19044
215-947-8306