The FDA, the UDI law, GS1 and Two Pivotal Dates: 10/12/09 and 10/20/09

Here’s a look at an email we got from GS1 Healthcare US about the upcoming UDI Conference being held October 20-21, 2009, in Orlando, Florida. It says attendees can expect to receive first-hand information on the progress and direction of the Food and Drug Administration’s (FDA) Unique Device Identification (UDI) draft regulation at this [...]

GS1 to be the Standard for UDI in China

Big news: In an email today from John Roberts, Director, GS1 Healthcare US, we’re being informed that at a recent seminar in China conducted by AdvaMed, which is a major association of advanced medical technology producers, officials representing the China State Food and Drug Administration (SFDA) said they plan to follow the  

‘Emerging Markets’ Label No Longer Applicable Says Financial Expert – But GS1 Labeling Is Still Very Applicable

In an online story from the UK’s Financial Times, writer Marko Dimitrijevic says this: The term emerging markets is obsolete. They represent half of the world’s economy; their financial markets are large and liquid, with volatility, corporate governance and government policies very similar to those of developed markets. The traditional distinctions between emerging and developed markets, once [...]

Oracle, Healthcare, GS1 Germany, the Upcoming OpenWorld Panel and a Request

I’ll be at the upcoming Oracle OpenWorld event starting October 12th in San Francisco. Loftware will have a booth (3108) and I will be participating on an important panel with Oracle, the FDA and GS1 that will spotlight healthcare applications with a special emphasis on supply chain safety and standards.  

To Expand Emerging Market Presence Abbott Labs to Buy Belgium Pharma Business for $6.6 Billion

This news came over the wire via the Associated Press (AP) at 3:33am this morning:

GS1 Importance in Emerging Markets: Brazil And GS1 Standards for Labeling

Brazil is the “B” in the shorthand for emerging markets sometimes lumped together as BRIC. Quite often here we’ve been covered news for two simultaneous points: emerging markets offer tremendous growth opportunities during this period of economic malaise in developed countries and, two, these emerging markets are making important contributions to the adoption and enforcement [...]

GS1 Standards Development Autumn Event Details Released

The GS1 Standards Development Event Autumn  

Emerging Markets the New ‘Friendly Skies’ Says Airbus COO

Previously here we commented on the bright future for focuing on emerging markets (and the requisite emerging markets label requirements, largely consisting of . . . GS1 compliance).  

“Oracle, the FDA, GS1 and Loftware: Improving Supply Chain Safety and Standards” – Up-Coming OpenWorld Panel!

Editor’s note: As an editorial decision since the inception of this blog, I’ve steered away from Loftware promotional posts. The panel session cited above, in my opinion, is news and the fact Loftware is in the middle of it, well, does it lose its news worthiness and become an ad? No, I don’t think so.
Announced [...]

Emerging Markets One Key to the ‘New’ Merck – All of Them Require GS1 Compliance

You probably know that Merck & Co., Inc. and Schering-Plough are merging. But as of today, we now know more about the direction of the combined entities. According to Richard T. Clark, who is chairman, president and chief executive officer of the ‘new’ Merck, the company will look at three key areas for growth as [...]

Autumn Report Promised on Use of GS1’s GDSN Among Healthcare Supply Chain Partners

At this link you can sign up to be on a mailing list which will alert you to a report scheduled for release this fall from GS1 Healthcare US on progress being made to implement GS1’s Global Data Synchronization Network® (GDSN®) in U.S. healthcare supply chains.  

The High Cost and Investment Risk of Proprietary HCIT Solutions

David Pogue of The New York Times has written this interesting and positive story entitled, “Charting a New Course,”  

Emerging Markets Drive Globalization, Driven by Recession, says BCG Partner – More Markets Mean More GS1 Compliance

Harold L. Sirkin is a Chicago-based senior partner of The Boston Consulting Group and author, with James W. Hemerling and Arindam K. Bhattacharya, of GLOBALITY: Competing with Everyone from Everywhere for Everything.
In a recent BusinessWeek  viewpoint he summarized why he thinks history will show that these current economic times spurred a tremendous era of globalization,  

Newly-Formed GS1 MobileCom Steering Committee Being Led by Nestlé, Kraft, J&J, Wal-Mart, Metro and Carrefour

This news was issued just yesterday by GS1 out of Brussels, Belgium. As you may know from previous posts here about GS1 MobileCom and its various workgroups, handbooks and white papers, it is a cross-industry initiative involving over one hundred companies seeking agreement on open standards that ensure interoperable, scalable and cost-effective mobile applications.

GS1 Healthcare Focus in Upcoming Presentation at HL7 Meeting

In a news release today, the Premier Healthcare Alliance, which represents  more than 2,200 U.S. hospitals and 63,000-plus other healthcare sites, announced upcoming presentations its senior executives will be making around the country in the coming days and months. Premier, you’ll recall, was the first group purchasing organization to endorse the use of GS1 supply [...]

FDA’s UDI Implementation will Target Class III Devices First

I should have caught this in July when FDA NEWS posted this update from Jay Crowley, who is the Food and Drug Administration’s senior adviser for patient safety:

Emerging Markets are Key to California Semiconductor Firm’s Growth Strategy And That Means GS1 Labeling

A company called Amalfi Semiconductor, which is based in Los Gatos, California,

Cadbury’s Emerging Market Strengths Driving Kraft’s Acquisition Interest

The headline on this Wall Street Journal article not only says it all, but validates the emerging markets focus we’ve been featuring here for months.  

GS1 Healthcare US Launches New Online Healthcare Supplier Tool Kit

Thanks to a timely and informative email today from GS1 Healthcare US President Dennis Harrison, we can confirm that the new online Healthcare Supplier Tool Kit developed by the Location Identification, Product Identification and GDSN Implementation workgroups is being launched.

New FDA Reporting Requirement To Make Food Safer?

The Food and Drug Administration on Tuesday unveiled a new electronic database where manufacturers must notify the government if they believe one of their products is likely to cause sickness or death in people or animals.