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Archive for December, 2009

Revisiting Reimportation

Tuesday, December 29th, 2009

At what cost could FDA be forced to change its tune on reimportation? "The Administration supports a program to allow Americans to buy safe and effective drugs from other countries and included $5 million in our FY 2010 budget request for the Food and Drug Administration (FDA or the Agency) to ...

Speak out about Sustainability

Monday, December 28th, 2009

A new task group has been added to the Institute of Packaging Professional's (IoPP) Medical Device Packaging Technical Committee (MDPTC). The Sustainability Task Group was announced this month, with the intention of focusing on "the unique challenges sustainability brings to the medical packaging industry, reported MDPTC co-chairs Alison Tyler of ...

Security For Medical Device Packaging

Wednesday, December 23rd, 2009

Oliver-Tolas Healthcare Packaging  (Grand Rapids, MI) has launched a range of technologies for brand identity reinforcement and protection from counterfeiting.  The technologies can be used for overt visual assurance of a package's authenticity and in a multi-layered approach using a Micro Text solution that Oliver-Tolas has also announced. "Medical device counterfeiting ...

Continuing Contamination

Thursday, December 17th, 2009

There's been another case of metal-contaminated vials. What could be the cause? The Medicines Company announced yesterday that it is voluntarily recalling eleven lots of Cleviprex injectable emulsion because of potential particulate matter observed in some vials during a routine annual inspection. The company has not received any product complaints or ...

Can Tamper Evidence Reduce Risk?

Friday, December 11th, 2009

Recent cases of syringe tampering have made me wonder: Should prefilled syringes carry tamper evidence as part of a risk-mitigation strategy? Tamper-evident packaging is not required for prescription drugs. According to an FDA spokesperson, "the regulation that requires tamper-evident packaging (21 CFR 211.132) applies only to over-the-counter drugs, not prescription drugs." ...

First Glue, Now Tape?

Monday, December 7th, 2009

Demerol has been victimized again. The U.S. Department of Justice United States Attorney District of New Hampshire reported that Trinidad Smith, of Manchester, NH, pleaded guilty to an indictment charging her with violations involving consumer product tampering and obtaining a controlled substance by fraud or deception. Smith was a registered nurse ...

Could Packaging Innovation Help Gather Data for Comparative Effectiveness?

Wednesday, December 2nd, 2009

Last week President Obama formed the Presidential Commission for the Study of Bioethical Issues. I wonder whether it will begin by defining Comparative Effectiveness Research (CER)? Critics argue that CER could be a tool for rationing healthcare. But I wonder whether CER could push for greater product and procedural innovation, ...