Webinar: How Can You Quickly Adopt Data Standards for Unique Device Identification?

Loftware is pleased to announce, as an extension of our blog, a series of educational webinars to focus on the process of meeting unique device identification requirements and the adoption of GS1 data standards.
Our kick-off session will be held on December 1, 2009 and registration can be found here.
This first session will focus on the [...]

VHA Asks FDA for Speedy UDI Decision; Inclusion of Only GS1 Standards as Single Mandatory Solution

This news comes from Healthcare Purchasing News:  VHA Inc. and 13 of its largest health system members have sent a letter to the U.S. Food & Drug Administration requesting prompt issuance of Unique Device Identification (UDI) regulations, and that those regulations include  GS1 supply chain standards. At this link, you can see the full release direct [...]

FDA Launches New ‘Safe Use Initiative’ to Reduce Medication Errors

I go to the U.S. Food and Drug Administration (FDA) website almost every day to glimpse their recent news releases. That’s because sometimes their announcements don’t seem to get much pick up in the usual places. Yesterday they issued this news release. The headline is: FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication [...]

Online Videos and Presentations from 15th Global GS1 Healthcare Conference Now Available

GS1 has alerted us to the availability of online videos and presentations captured in Hong Kong in early October during the GS1 Healthcare Conference.  

First View of FDA UDI Regulations . . . Just Hours Away?

This is a reminder of the UDI 2009 Conference that gets underway twelve hours from now, in Orlando. Take a look at this event site and tell me it doesn’t have ‘decision-time’ written all over it.  

FDA’s Jay Crowley to give UDI Keynote at Upcoming Virtual Trade Show

“The Upside of a Unique Device Identification (UDI) Mandate” is the topic of an online keynote speech that will be given by Jay Crowley, senior advisor for patient safety, Center for Devices and Radiological Health, of the U.S. Food and Drug Administration (FDA) on December 2 as part of the Track & Trace Virtual Trade Show. 

In Emerging Markets, Big Pharma Pursuing ‘Branded Generics’ Strategy — Still Means GS1 Barcodes On Market Compliant Labels

In this article, entitled “Major pharmaceutical companies see generics as a bridge to the future,” writer Clay Boswell first provides a review of all the major acquisitions, mergers and joint marketing agreements by large pharmaceutical companies over the past couple of years.  

AP Story Slams Lack of Medical Device Tracking; FDA’s UDI Labeling Gets Brief Mention As Answer

The Associated Press put out a story today that’s getting a lot of traction and that’s good because this report, entitled “US has no good system to track medical implants” is bound to get a lot of average people interested very quickly in what needs to happen. It also might get a lot of the [...]

Oracle OpenWorld Panel Update: “Oracle, the FDA, GS1, and Loftware: Improving Supply Chain Safety and Standards”

By now you’re aware of the upcoming Oracle OpenWorld event starting  

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, 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 [...]

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:

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.

FDA to Require Electronic Safety and Adverse Event Reports by 2010

The US Food and Drug Administration (FDA) plans to make electronic filing of safety reports mandatory by this time next year according to this news report in Government Health IT. It is a change the FDA says will help it detect emerging safety problems sooner and respond with safety information to the public in less [...]

As Loftware Preps for Oracle OpenWorld, 11g R2 Debuts

This is the first of several planned posts about a major healthcare technology panel at Oracle OpenWorld 2009 in San Francisco (where Loftware will also be exhibiting in booth 3108, West Exhibition Hall). While Oracle’s chief focus this year at the October show is rightfully on their formal launch yesterday of 11g Release 2 of its database, [...]

FDA’s Top Medical Device Regulator Quits; More Turmoil on Horizon?

Medical device manufacturers are already facing some uncertainty about impending rules for device identification. Now, they also face a new regulator.

FDA Visits Foreign Manufacturers of Medium Risk Medical Devices Once Every 27 Years

Some days I am very optimistic about the changes afoot to make the Food and Drug Administration a stronger, more powerful place. New

Strong Food Safety Bill Working its Way Through Congress

File this under, ‘It’s about time!” The US House of Representatives has passed a bill that will require more food safety measures. It will give more power to the FDA in demanding recalls and creating a better product tracing