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Archive for January, 2011

Are Your Packaging and Labeling Processes Ready for Unique Device Identification?

Wednesday, January 26th, 2011

We are all patiently awaiting FDA's draft regulations on Unique Device Identification. Could they come in February? How far will they go? FDA's Jay Crowley, senior advisor for patient safety, will be speaking at an FDAnews event February 24, "Complying with FDA's Unique Device Identification Rule: Unlocking the Secrets of Effective ...

Making the Case for Labeling Distinction

Thursday, January 13th, 2011

In its December 16 issue, the Institute for Safe Medication Practices (ISMP) shared a report that unit-dose packages of Curad's petroleum jelly were mixed up with those of triple antibiotic ointment, resulting in the wrong product being applied to an infant in intensive care. (Not sure which one should have ...

What New Laws Will 2011 Bring?

Friday, January 7th, 2011

I was asked for a legislative update on pharmaceutical quality and security efforts a while ago, so I searched thomas.gov and found the below. I thought I would share it because 2011 may bring some changes--although it is still early! Of all the pharmaceutical related bills last year, these seem to ...

Looking for the Next Award Winner!

Wednesday, January 5th, 2011

You work pretty hard to develop packaging for life-saving products, so don't miss out on your chance for industry recognition! One precious bit of advice I have heard from one of our editorial advisory board members: "Without well-designed packaging, your medical device isn't a market-ready product," or something along those ...