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Type: News

Section: Industry News > Regulatory

Supply Chain

Medical Device Packaging Insights

Read three separate reports from February's Medical Device & Manufactur-ing show in Anaheim covering:

May 9, 2007

Regulatory

Clinical Trials Outsourced To China

Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney (www.atkearney.com), "Make Your Move: Taking Clinical Trials to the Best Location." The report cites China as the best bet for outsourcing clinical trials. According to an article posted on DrugResearcher.com http://www.drugresearcher.com/news/ng.asp?id=72702, China was chosen both for cheap labor and facilities, as well as a huge urban patient pool.

May 9, 2007

Regulatory

Clinical Trials: India Announces Tax Exemption

In the past 10 years, "skyrocketing costs of R&D have led to a growth explosion in the clinical services industry as pharma companies scramble to cut costs." So said Outsourcing-Pharma.com in its February 28 report, "Clinical trials in India just got cheaper."

May 9, 2007

Medical Device/Packaging

FDA's Marlowe Addresses Medical Device Makers

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year's HealthPACK medical device conference in New Orleans.

May 9, 2007

Regulatory

Purdue Pharma To Deploy Gen 2 Tagging On Packaging line

In February, radio-frequency identification (RFID) chip and reader supplier Impinj (www.impinj.com) announced that Stamford, CT-based Purdue Pharma LP plans to deploy item-level Generation 2 RFID tagging on a major packaging line. Impinj's Grand-Prix ultra-high-frequency system includes Speedway readers, tags powered by Monza chips, plus application-specific near-field reader antennas.

May 9, 2007

Regulatory

Healthcare Packaging Minute

Aylward Enterprises appoints Dana S. Waterman as CEO... Hubert H. Keil, managing director and CEO of Uhlmann Packaging Systems, was appointed vice chairman of the Board of Directors of the Healthcare Compliance Packaging Council... TCP Reliable acquired the assets of Cryopak Industries... International Business Solutions Alliance, LLC signed an agreement with SATO America, Inc., to offer a more secure method of administering patient care and improved patient safety through SATO's Positive Patient Identification solution... Paxonix and Global Vision have formed a drug packaging partnership to help companies reduce packaging blunders and meet compliance and validation demands... Oracle acquired Tolas Healthcare Packaging... Perfecseal will expand several facilities, including those in New London, WI; Derry, Northern Ireland; and Selangor, Malaysia.

May 9, 2007

Adherence/Delivery

Futuristic Pill Container Zaps Prescription Meds

Beware drug abusers and diverters: Attempts to tamper with this pill container will result in the disintegration of its contents in a puff of smoke.

May 9, 2007

Supply Chain

ISPE Addresses Pharmaceutical Packaging

Late last year, the International Society for Pharmaceutical Engineering (www.ispe.org) introduced a new packaging Community of Practice (COP). The COP held its first meeting at ISPE's annual meeting in Orlando, FL. Chairing the packaging COP's Steering Committee is Linda McBride, senior director of regulatory affairs for Leawood, KS-based medical firm Enturia, Inc. (formerly Medi-Flex). McBride is a former columnist for Healthcare Packaging.

May 9, 2007

Regulatory

We Haven't Heard The End Of The Ketek Saga

Ketek (telithromycin) is an antibiotic first approved by the Food and Drug Administration in 2004. The Sanofi-Aventis product used to treat a form of pneumonia is the subject of ongoing controversy, with some fingers pointing at the company and some at the FDA.

May 9, 2007

Supply Chain

Healthcare enters time of profound change

Attention packagers in the healthcare business: Healthcare has entered a time of profound change. That's according to TRAX: Pharmaceutical Supply Chain Integrity, a conference held May 3-4 in Baltimore and produced by the Institute for International Research. The conference brought the following ideas to its audience:

May 8, 2007

Regulatory

Top 10 FDA developments

Packaging World and Healthcare Packaging columnist and attorney-at-law Eric F. Greenberg offered a list of key issues pertaining to healthcare packaging during the Pharmaceutical Packaging Forum. To read the complete story, please click here.

May 4, 2007

Pharmaceuticals

Repackaging 'releevs' theft woes

Merix Pharmaceutical Corp. switched its retail packaging for Releev 1 Day Cold Sore Symptom Treatment to BlisterGuard security package from Colbert Packaging to thwart tampering and pilferage and meet retailer demands.

April 13, 2007

Regulatory

RFID smart shelves and cabinets

So-called smart packaging has been around for years, but what about "smart shelves"?

March 23, 2007

Medical Device/Packaging

11607 compliance requires strategic planning

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show.

March 23, 2007

Labeling/Printing

ISPE addresses pharmaceutical packaging

Late last year, the International Society for Pharmaceutical Engineering introduced a new packaging Community of Practice (COP). The COP held its first meeting at ISPE's annual meeting in Orlando, FL. Chairing the packaging COP's Steering Committee is Linda McBride, senior director of regulatory affairs for Leawood, KS-based medical firm Enturia, Inc. (formerly Medi-Flex). McBride is a former columnist for Healthcare Packaging.

March 10, 2007

Supply Chain

Package testing tips and insights

Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, "Medical Device Distribution Package Testing," during the Medical Device & Manufacturing (MD&M) West show.

March 10, 2007

Regulatory

Clinical trial packaging survey

Benchmark yourself against your peers when it comes to clinical trial packaging.

March 8, 2007

Pharmaceuticals

Repackaging 'releevs' theft woes

Merix Pharmaceutical Corp. switched its retail packaging for Releev 1 Day Cold Sore Symptom Treatment to the BlisterGuard security package from Colbert Packaging to thwart tampering and pilferage and meet retailer demands. This new format introduced last September is now used nationwide at Walgreens and Kmart stores, with expanded retail distribution planned throughout 2007.

February 19, 2007

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